GUIDE TO MEDICAL / PARAMEDICAL PRACTITIONERS

LIST OF DANGEROUS DRUG PREPARATIONS (DDPs)

ACQUISITION / DISPENSING / PRESCRIBING:

To be purchased through an approved PDEA Form 1-04 (Local Order Permit). To be prescribed and
dispensed through the DOH Special Prescription Form for Dangerous Drugs. Only one (1) dangerous
drug preparation shall be prescribed in one single prescription form. Partial filling allowed. STRICTLY NO
REFILL.

RECORDING / REPORTING:
To be recorded in an appropriate Dangerous Drugs Register in accordance with the PDEA-prescribed
format. To submit semi-annual report not later than January 15 and July 15 of each year.

LICENSE REQUIRED:
Prescribing Physician / Dentist / Veterinarian S2 License
Retail Dealer of DDPs S3 License
Wholesaler Dealer of DDPs S4 License
Manufacturer / Repacker of DDPs S5-C License
Importer of DDPs S5-I License
Exporter of DDPs S5-E License

Dangerous Drug Brand Name, Importer (I) / Distributor (D) /

(Active Ingredient) Dosage Form & Strength / CPR Manufacturer (M)
* ALTROX I/D:Torrent Pharmaceuticals,
ALPRAZOLAM 250mcg Tablet Ltd
Blister 10s, Box 100s
FDA Reg. No.: DRP 3132 Manufactured in: India
Valid until 11 APRIL 2021
* ALTROX I/D:Torrent Pharmaceuticals,
500mcg Tablet Ltd
Blister 10s, Box 100s
FDA Reg. No.: DRP 3180 Manufactured in: India
Valid until 26 JUNE 2021
* AXAL I/D: Sahar International
250mcg Tablet Trading, Paranaque, City
Blister 10s, Box 30s
FDA Reg. No.: DR-XY 38992 Manufactured in: Pakistan
Valid until 27 JAN 2021
* AXAL
500mcg Tablet
Blister 10s, Box 30s
FDA Reg. No.: DR-XY38855
Valid until 27 JAN 2021
* AXAL
1mg Tablet
Blister 10s, Box 30s
FDA Reg. No.: DR-XY 38993
Valid until 27 JAN 2021

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 * SERELAM I/D: Ambica Int’l Trading
250mcg Tablet Corp, Pque
Blister 10s, Box 100s
FDA Reg No. DRP-5103 M: General Pharmaceuticals
Valid until 12 FEB 2019 Limited, Bangladesh
Validity is extended for 1 yr 12 FEB 2020
under RENEWAL DTN:20181204153841
* SERELAM
500mcg Tablet
Blister 10s, Box 100s
FDA Reg No. DRP-3720
Valid until 17 APRIL 2017
RENEWED WITH OR# 0846187
DATED APRIL 7, 2017
* XANOR I / D: Pfizer
250mcg Tablet
Blister 10s Box 100s Manufactured in: Italy
FDA Reg. No.: DRP 2146
Valid until 20 NOV 2021
* XANOR
500mcg Tablet
Blister 10s Box 100s
FDA Reg. No.: DR-XY 14607
Valid until 21 MAR 2020
* XANOR XR
500mcg Controlled Release Tablet
Blister 10s Box 100s
FDA Reg. No.: DRP-2048
Valid until 4 MAY 2023
* XANOR
1mg Tablet
Blister 10s Box 100s
FDA Reg. No.: DR-XY16774
Valid until 21 MAR 2020
* ZOLDAC I/D: Zydus Philippines, Inc
250mcg Tablet
Blister 10s, Box of 30s Manufactured in: India
FDA Reg. No.: DX- XY 45450
Valid until 16 JUN 2021
* ZOLDAC I/D: Zydus Philippines, Inc
500mcg Tablet
Blister 10s, Box 30s Manufactured in: India
FDA Reg. No.: DR-XY 45396
Valid until 23 MAY 2021
* ZOLGEN M: Lloyd Laboratories Inc
500mcg Tablet
Blister 10s, Box 100s T: Innogen Pharmaceuticals,
FDA Reg No.: DR-XY 39552 Inc
Valid until 01 JUNE 2018
* LEXOTAN I: Roche Phils., Inc.,
BROMAZEPAM 1.5mg Tablet Taguig City
Blister 10s, Box 100s
FDA Reg No: DR-XY40440
Valid until 22 DEC 2021

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 ** NORSPAN I/D: Mundipharma
BUPRENORPHINE 5mg Transdermal Patch DistributionGmbH (Philippine
Box 2s Branch)
FDA Reg. No. DR-XY35292
Valid until 24 NOV 2020 Manufactured in: Germany
** NORSPAN
10mg Transdermal Patch
Box 2s
FDA Reg. No. DR-XY 35290
Valid until 24 NOV 2020
** NORSPAN
20mg Transdermal Patch
Box 2s
FDA Reg. No. DR-XY 35291
Valid until 24 NOV 2020
** TRANSTEC I/D: Mundipharma Distribution
20mg (35mcg/h) Transdermal Patch GmbH (Philippine Branch)
Box 1s, 2s, 4s
FDA Reg. No: DR-XY 46026 Manufactured in: Germany
Valid until 8 SEPT 2022
** TRANSTEC
30mg (52.5mcg/h) Transdermal Patch
Box 1s, 2s, 4s
FDA Reg. No: DR-XY 46027
Valid until 8 SEPT 2022
* CLONOTRIL-0.5 I/D: Torrent Pharma Phils Inc
CLONAZEPAM 500mcg (0.5mg) Tablet
Blister 10s, Box 20S & 100s M: Torrent, India
FDA Reg No: DRP-2810
Valid until 29 AUG 2023
* CLONOTRIL-2 I/D: Torrent Pharma Phils., Inc
2mg Tablet
Blister 10s, Box 100s M: Torrent Pharmaceuticals
FDA Reg No: DRP-2809 Ltd., India
Valid until 02 SEP 2023
* EPILINE 2 I/D: Zydus Healthcare
2mg Tablet Philippines, Inc,
Blister 10s
FDA Reg No: DR-XY 44549
Valid until 27 MAY 2020
* RIVOTRIL I: Roche Phils., Inc, Makati
2mg Tablet City
Bottle 100s D: Zuellig Pharma Corp.,
FDA Reg. No. DR-XY37012 Makati City
Valid until 19 NOV 2019 Manufactured in: Spain
* TRANXENE I: Sanofi-Aventis, Phils, Inc.
CLORAZEPATE DIPOTASSIUM 5mg Capsules Manufacturer: Sanofi-Aventis,
Blister 10s, Box 30s Spain
FDA Reg. No. DR-X1254
Valid until 14 OCT 2022 Repacker: Hizon Laboratories,
Inc.

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DIAZEPAM ANXIOL I / D: Endure Medical Inc.,
5mg/mL, 2ml (10mg/ 2ml) Ampule Pasig City
Box 10s
FDA Reg. No. DR-XY29833 Manufactured in: Taiwan
Valid until 9 AUG 2022
ANXOL I/D: Ambica Intl Trading Corp,
5mg/ml (10mg/2ml) IM/IV Ampule Paranaque
Box 10s
FDA Reg No DRP-4175 M: India
Valid until 16 DEC 2019
LORCAM I / D: Lordla Pharma Sales,
5mg/mL, 2mL Ampule Quezon City
Box 50s
FDA Reg. No. DR-XY22760-B M: Thailand
Valid until 20 NOV 2018
RENEWED WITH OR# 1048278
DATED NOV 7, 2018
TRANKIL I/D: Duopharma Trade Phils
5mg/mL, 2ml Ampule
Box 10s M: Rotexmedica, GmBH,
FDA Reg. No. DR-XY29949 Germany
Valid until 03 SEP 2019
VALIUM
5mg/mL, 2ml Ampule I: Roche Phils., Inc., Taguig
Box 10s City
FDA Reg No. DR-6298
Valid until 14 APR 2023 D: Zuellig Pharma
* VALIUM Corporation, Pque City
5mg Tablet
Blister 25s, Box 100s Manufactured in: France
FDA Reg. No. DR-XY37749
valid until 30 JAN 2020
* VALIUM
10mg Tablet
Blister 25s, Box 100s
FDA Reg. No. DR-XY37748
Valid until 7 APR 2021
*VEXEPAM I/D: Phil Pharmawealth, Inc
5mg Tablet
Blister 10s, Box 100s Manufactured in: India
FDA Reg No. DR-XY41080
Valid until 26 JULY 2020
*VEXEPAM
10mg Tablet
Blister 10s, Box 100s
FDA Reg No. DR-XY41081
Valid until 26 JULY 2020
EPHEDRINE SULFATE M: Hizon Laboratories, Inc
EPHEDRINE 50mg/mL, 1mL Ampule
Box 100s
FDA Reg No. DR-4468
Valid until 21 FEB 2023

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 FEDRIN I/D: Sahar International
30mg/mL, 1mL Ampule
Box 5’s M: Pakistan
FDA Reg No. DR-XY41068
Valid until 18 JULY 2022
ABSTRAL T: A.Menarini Philippines, Inc
FENTANYL 100mcg Sublingual Tablet
Blister 10s, Box 10s & 30s Manufactured in: United
FDA Reg No. DR-XY45371 Kingdom
Valid until 11 MAY 2021
ABSTRAL
200mcg Sublingual Tablet
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45372
Valid until 11 MAY 2021
ABSTRAL
300mcg Sublingual Tablet
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45370
Valid until 11 MAY 2021
ABSTRAL
400mcg Sublingual Tablet
Blister 10s, Box 10s & 30s
FDA Reg No. DR-XY45367
Valid until 11 MAY 2021
ABSTRAL
600mcg Sublingual Tablet
Blister 10s, Box 30s
FDA Reg No. DR-XY45369
Valid until 11 MAY 2021
ABSTRAL
800mcg Sublingual Tablet
Blister 10s, Box 30s
FDA Reg No. DR-XY45368
Valid until 11 MAY 2021
DUROGESIC D-TRANS Importer: Johnson & Johnson
12mcg/hr Transdermal Patch Distributor: Zuellig Pharma
Box 5s Corp
FDA Reg No. DR-XY33326
Valid until 29 DEC 2020 Manufactured in: Belgium
DUROGESIC D-TRANS
25mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DR-XY33327
Valid until 29 DEC 2020
DUROGESIC D-TRANS
50mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DR-XY33325
Valid until 29 DEC 2020
FENDERMAL I: Sandoz Phils Corp, Makati
12.5mcg/hr Transdermal Patch
Box 5s M: Germany
FDA Reg No. DRP-4099
Valid until 14 NOV 2022

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FENDERMAL
25mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DRP-4112
Valid until 22 NOV 2022
FENDERMAL
50mcg/hr Transdermal Patch
Box 5s
FDA Reg No. DRP-4111
Valid until 22 NOV 2022
FENTANYL CITRATE I: Pfizer
50mcg/mL, 2mL, Ampule M: in USA
10’s
FDA Reg No. DR-XY17752
Valid until 07 NOV 2022
FENTANYL CITRATE I/D: Pfizer
50mcg/ml, 2mL & 10mL Ampule
5’s M: in Germany
FDA Reg No. DR-XY32871
Valid until 06 FEB 2022
FENTYN Importer: Sandoz Philippines
25mcg/hr Transdermal Patch Corporation
Sachet, Box 5s Distributor: United
FDA Reg No. DRP-4112-01 Laboratories
valid until 22 NOV 2022 Manufactured in: Germany
FENTYN Importer: Sandoz Philippines
50mcg/hr Transdermal Patch Corporation
Sachet, Box 5s Distributor: United
FDA Reg No. DRP-4111-01 Laboratories
valid until 22 NOV 2022 Manufactured in: Germany
FRESANYL Importer/Distributor: Fresenius
50mcg/ml (100mcg/ 2ml) Kabi Philippines
Type 1 amber glass 2 ml ampule 10s
Type 1 amber glass 10 ml ampule 5s Manufactured in: Africa
FDA Reg No. DR-XY45908
Valid until 24 MAY 2022
SUBLIMAX I/D: Endure Medical Inc, Pasig
50mcg/mL, 2mL Ampule
Box 10s M: China
FDA Reg No. DR-XY43003
Valid until: 22 NOV 2023
SUBLIMAZE Importer: Johnson & Johnson
50mcg/mL, 2mL & 10mL Ampule Philippines, Inc
Box 5s D: Zuellig Pharma Corp
FDA Reg No. DR-XY22177 Manufactured by: GSK, Italy
Valid until 29 JULY 2023
TROFENTYL Importer/Distributor:
50mcg/mL, 2ml Pharmasan Inc
Ampule, Box 5s
FDA Reg No. DR-XY35224 Manufacturer:Troikaa
valid until 11 DEC 2020 Pharmaceuticals, India

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 ETAMINE M: Swiss Parenterals, India
*KETAMINE HCL 50mg/mL Vial I/D: Endure Medical, Inc
Box 1s
FDA Reg No: DR-XY41256
Valid until 19 SEPT 2022
KETAMAX I/D: Duopharma Trade Phils
50mg/mL, 10mL Vial
Box 1’s Manufactured in: Germany
FDA Reg No. DR-XY19615
Valid until 17 FEB 2020
KETAROL I/D:Surestep Pharmaceuticals
50mg/mL, 10mL Vial Inc, Pque City
Box 1s
FDA Reg No. DR-XY41210 M: Pakistan
Valid until 11 SEPT 2022
UNIKET I/D: Claris Lifesciences Phils
50mg/mL, 10mL Vial
Box 5s Manufactured in India
FDA Reg No. DR-6820
Valid until 13 OCT 2023
CONCERTA I: Johnson & Johnson Phils
METHYLPHENIDATE HCL 18mg Extended Release Tablet Inc., Pque City
Bottle 30s D: Zuellig Pharma Corp, Pque
FDA Reg No. DR-XY27940 City
Valid until 03 AUG 2022 M: Puerto Rico
CONCERTA I: Johnson & Johnson Phils
27mg Extended Release Tablet Inc., Pque City
Bottle 30s D: Zuellig Pharma Corp, Pque
BFAD Reg No. DR-XY30659 City
Valid until 22 JULY 2020 M: Puerto Rico
CONCERTA I: Johnson & Johnson Phils
36mg Extended Release Tablet Inc., Paranaque City
Bottle 30s D: Zuellig Pharma Corp, Pque
FDA Reg No. DR-XY27941 City
Valid until 03 AUG 2022 M: Puerto Rico
RITALIN I: Novartis Healthcare Phils.,
10mg Tablet Inc., Makati City
Blister 15’s, Box 30s
FDA Reg No. DR-XY28528 Manufactured in: Spain
Valid until 10 APRIL 2023
RITALIN LA I: Novartis Healthcare Phils.,
20mg Modified Release Capsule Inc., Makati City
HDPE bottle of 30s
FDA Reg No. DR-XY43804 Manufactured in: USA
Valid until 14 OCT 2019
RITALIN LA
30mg Modified Release Capsule
HDPE bottle of 30s
FDA Reg No. DR-XY43805
Valid until 14 OCT 2019
RITALIN LA
40mg Modified Release Capsule
HDPE bottle of 30s
FDA Reg No. DR-XY43806
Valid until 14 OCT 2019

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MIDAZOLAM DORMICUM I/Trader: Roche Phils Inc.,
1mg/mL, 5mL (5mg/ 5ml) Ampule Taguig City
Box 10s
FDA Reg No: DR-XY28582 D: Zuellig Pharma Corp,
Valid until 28 APR 2023 Paranaque City
DORMICUM
5mg/mL, 3mL (15mg/3ml) Ampule Manufactured in: France /
Box 5s Switzerland
FDA Reg No: DR-XY28583
Valid until 28 APRIL 2023
DORMICUM
5mg/mL, 1mL Ampule
Box 10s
FDA Reg No: DR-XY28584
Valid until 28 APR 2023
* DORMICUM
15mg Tablet
Blister 10s, Box 100s
FDA Reg No: DR-XY3516
Valid until 10 JAN 2021
DORMID Importer/Distributor: Endure
1mg/ml (5mg/5ml) Medical Inc
Ampule, Box 10s
FDA Reg No. DR-XY44212 Manufactured in: Indonesia
Valid until 15 FEB 2021
DORMID
5mg/ml (15mg/3ml)
Ampule, Box 5s
FDA Reg No. DR-XY44213
Valid until 15 FEB 2021
DORMIZOL I/D: Phil Pharmawealth, Inc.
5mg/mL, 1mL, 3mL Ampule
Box 10s M: India
FDA Reg No: DR-XY41527
Valid until 18 MAR 2023

HYPOZAM I/D: Sahar Intl Trading Inc,

1mg/mL, 3mL & 5ml, Ampule Pque City
Box 10s
BFAD Reg No.: DR-XY38463 Manufactured in: Pakistan
Valid until 14 SEPT 2020
MIDAZOLAM I/D: Int’l Apex Pharmls, Inc
1mg/mL, 5mL and 1mL, Vial
M: Pakistan
FDA Reg No: DR-XY41312
Valid until 05 NOV 2022
MIDAZOLEX I/D: Metrophil Drug and
1mg/mL, 5ml Ampule Chemical Trading
Box 10s M: Korea
FDA Reg No: DRP-4892
Valid until 05 APR 2023

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 MIDAZOLEX I/D: Metrophil Drug and
5mg/mL, 3ml Ampule Chemical Trading
Box 5s M: Korea
FDA Reg No: DR-XYR1894
Valid until 05 APR 2023
MIZAM I:Surestep Pharmaceuticals
1mg/mL, 5mL Ampule Inc. (Paranaque City)
Box 10s
FDA Reg No : DR-XY40893 M: Pakistan
Valid until 02 AUG 2022
SEDACUM I: Glorious Dexa Mandaya
5mg/mL, 3ml Ampule
Box 5s
FDA Reg No : DR-XY42116
Valid until 13 JUNE 2021
SEDOZ I/D: Claris Lifesciences Phils.
1mg/mL, 5ml Ampule Inc., Makati City
Box 25s
FDA Reg No : DR-XY30768 Manufactured in: India
Valid until 23 MAY 2020
SEZOLAM
5mg/ml, 3 ml Ampule
Box of 5s,10s, 25s
FDA Reg No : DRP-6984
Valid until : 5 DEC 2023
MORPHINE SULFATE M: Hizon Labs, Antipolo City
MORPHINE SULFATE 10mg Tablet
Strip Foil 4s, Box 100s
FDA Reg No: DR-XY27441
Valid until 17 JUN 2020
MORPHINE SULFATE
30mg Tablet
Strip Foil 4s, Box 100s
FDA Reg No: DR-XY27463
Valid until 17 JUN 2020
MORPHINE SULFATE
(1/4grain) 16mg/mL, 1ml, Ampule

FDA Reg No: DR-9210

Valid until 05 SEP 2022
MORPHINE SULFATE
(1/6grain) 10mg/mL, 1ml, Ampule
Box 100s
FDA Reg No: DR-9208
Valid until 31 MAY 2020
MORPHINE SULFATE I/D: Pfizer (Hospira Phils)
10mg/mL, 1ml, Ampule
Box 5s M: in Germany
FDA Reg No: DR-XY33322
Valid until 18 MAY 2022
MST CONTINUS I: Mundipharma Distribution
10mg Modified Release Tablet GmbH (Philippine Branch)
Blister 30s, Box 60s
FDA Reg No: DR-XY13020 Manufactured in: United
Valid until 17 JUL 2021 Kingdom

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 MST CONTINUS
30mg Modified Release Tablet
Blister 30s, Box 60s
FDA Reg No: DR-XY13019
Valid until 17 JUL 2020
MST CONTINUS
60mg Modified Release Tablet
Blister 30s, Box 60s
FDA Reg No: DR-XY13021
Valid until 16 JUL 2023
ANALIN I/D: Sahar Intl Trading
*NALBUPHINE 10mg/mL, 1ml, ampule
Box 10s M: Pakistan
FDA Reg. No. DR-XY35860
Valid until 21 MAY 2020
ANALIN
20mg/mL, 1mL, ampule
Box 10s
FDA Reg. No. DRXY-40127
Valid until 5 OCT 2021
ENDURPIN I: Metrophil Drug & Chemical
10mg/mL, 1mL Ampule Trading
Box 10s D: Delex Pharma Intl Inc,
FDA Reg No: DRP-2110 M: Korea
Valid until 28 SEP 2019
NALBULIN I/D:
10mg/ml, 1ml, Ampule Surestep Pharmaceuticals,
Blister pack, 5s Inc.
FDA Reg No: DR-XY41208
Valid until 4 SEPT 2022 Manufactured in: Pakistan
NALBUPHINE HYDROCHLORIDE I/D: I.E Medica, Inc
10mg/ml, 1ml
Box 10s Manufactured in: India
FDA Reg No: DRP-7177
Valid until 19 MAY 2022
NALBUPHINE HYDROCHLORIDE
20mg/ml, 1ml
Box 10s
FDA Reg No: DRP-7166
Valid until 19 MAY 2022
NALBUPHINE HYDROCHLORIDE I/D: Hospira Phils/ Pfizer Inc.
(Preservative and Anti-Oxidant Free)
10mg/mL, 1ml, Ampule Manufactured in: USA
Blister 10s
FDA Reg No. DR-XY25633
Valid until 03 NOV 2019
NUBAIN T: A. Menarini Phils, Inc.,
10mg/mL, 1ml, Ampule Taguig City
Box 10s and 100s Under license from A.
FDA Reg. No. DR-X3037 Menarini Asia Pacific Holdings
Valid until 14 NOV 2023 Pte Ltd.– Singapore
M: Hizon Labs., Inc., Antipolo
City

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 NUKAINE I/D: International Apex
10mg/ml, 1ml Pharmaceuticals, Inc.
Box 100s
Blister 5s, Box 10s Manufactured in: Korea
FDA Reg No. DR-XY40522
Valid until 11 JAN 2020
SEDAFIN Importer/Distributor: Euro
10mg/ml, 1ml Generics International
Box 5s Philippines, Inc
FDA Reg No: DR-XY45030
Valid until: 4 FEB 2021 Manufactured: Bangladesh
OXYCONTIN I/D: Mundipharma Distribution
OXYCODONE HCL 10mg Prolonged Release Tablet GmbH (Philippine Branch)
Blister 14s, Box 28s Pasig City
FDA Reg No: DR-XY27751
Valid until 19 FEB 2021 Manufactured in: USA / UK
OXYCONTIN
20mg Prolonged Release Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY27748
Valid until 19 FEB 2021
OXYCONTIN
40mg Prolonged Release Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY27750
Valid until 19 FEB 2021
OXYCONTIN
80mg Prolonged Release Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY27749
Valid until 19 FEB 2021
OXYCONTIN NEO
10mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45704
valid until 15 DEC 2021
OXYCONTIN NEO
20mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45706
valid until 15 DEC 2021

OXYCONTIN NEO
40mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45708
valid until 15 DEC 2021
OXYCONTIN NEO
80mg Controlled Release Tablet
Blister 10s, Box 20s, 30s, & 40s
FDA Reg No: DR-XY45708
Valid until 15 DEC 2021

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 OXYNORM I: Mundipharma Distribution
5mg Capsule GmbH (Philippine Branch)
Blister Pack x 14s (Box of 28’s) Pasig City
FDA Reg No: DR-XY32009
Valid until 20 JULY 2019 M: Bard Pharmaceuticals
Validity is extended for 1 yr 20 JULY 2020 Limited, UK
under RENEWAL DTN:20181123103304
OXYNORM I: Mundipharma Distribution
10mg Capsule GmbH (Philippine Branch)
Blister Pack x 14s (Box of 28’s) Pasig City
FDA Reg No: DR-XY32011
Valid until 20 JULY 2019 M: Bard Pharmaceuticals
Validity is extended for 1 yr 20 JULY 2020 Limited, UK
under RENEWAL DTN:20181123103323
OXYNORM LIQUID I/D: Mundipharma Distribution
5mg/5ml Oral Solution GmbH (Philippine Branch)
Amber glass bottle, 250ml (1’s) Pasig City
FDA Reg No: DR-XY41366 Manufactured in: Cyprus
Valid until: 21 DEC 2019
OXYNORM I/D: Mundipharma Distribution
10mg/ml (20 mg / 2ml) GmbH (Philippine Branch)
Colorless glass ampule, 1ml and 2ml Pasig City
(Box of 5’s)
FDA Reg No: DR-XY36393 Manufactured in: Israel
Valid until: 11 MAY 2023
TARGIN I/D: Mundipharma Distribution
OXYCODONE 5mg/2.5mg Prolonged-Released Tablet GmbH (Philippine Branch)
WITH NALOXONE Blister 14s, Box 28s Pasig City
FDA Reg No: DR-XY42646
Valid until 18 SEPT 2019 T: Under License from
TARGIN Mundipharma Laboratories
10mg/5mg Prolonged-Released Tablet BmbH, Switzerland
Blister 14s, Box 28s
FDA Reg No: DR-XY40703 M: Bard Pharmaceuticals
Valid until 28 FEB 2020 Limited, UK
TARGIN
20mg/10mg Prolonged-Released Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY40700
Valid until 28 FEB 2020
TARGIN
40mg/20mg Prolonged-Released Tablet
Blister 14s, Box 28s
FDA Reg No: DR-XY40702
Valid until 28 FEB 2020
DOLETHAL Importer : Agfield International
PENTOBARBITAL SODIUM 200mg/ml, 100ml Corporation
Vial
FDA Reg No: VR-3537 Manufactured in : France
Valid until 15 SEPT 2019
PETHIDINE / MEPERIDINE DEMEROL I/D: Pfizer (Hospira Inc )
50mg/mL, 2mL, ampule
Box 25s Manufactured in: USA
FDA Reg No: DR-2148
Valid until 29 JULY 2019
RENEWED WITH OR# 1114468
DATED APRIL 24, 2019

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 DEMEROL
50mg/mL, 30mL, vial
Box 1s
FDA Reg No: DR-2149
Valid until 24 MAR 2023
DEMETOR Importer/Distributor: Endure
50mg/mL, (100 mg/ 2ml) Ampule Medical, Inc
Box 10s
FDA Reg No: DR-XY46256 Manufactured in: China
Valid until 19 FEB 2023

LUMINAL I: Pfizer (Hospira Inc )

PHENOBARBITAL SODIUM 130mg/mL, 1mL, ampule
Box 5s D: Zuellig Pharma
FDA Reg No: DR-X7787
Valid until 24 MAR 2019 Manufactured in : USA
*DISCONTINUED BY MANUFACTURER
* PHENOBARBITAL D: Philusa Corporation
15mg, Tablet
Bottle 100s M: Amherst Laboratories, Inc
FDA Reg No: DR-X1824
Valid until 29 MAY 2023
* PHENOBARBITAL
30mg, Tablet
Bottle 100s
FDA Reg No: DR-5064
Valid until 29 MAY 2023
* PHENOBARBITAL
60mg, Tablet
Bottle 100s
FDA Reg No: DR-X2017
Valid until 29 MAY 2023
* PHENOBARBITAL
90mg, Tablet
Bottle 100s
FDA Reg No: DR-XY21882
Valid until 29 MAY 2023
PHENTERMINE RESIN * DUROMINE I/D: Metro Drug Inc, Taguig
15mg capsule City
Blister 15s, Box 30s
FDA Reg No: DR-XY26998 Manufactured in: New
Valid until 26 MAR 2021 Zealand
* DUROMINE
30mg, capsule
Blister 15s, Box 30s
FDA Reg No: DR-XY26999
Valid until 26 MAR 2023
REMIFENTANIL SUBLIFEN I/D: Endure Medical Inc
HYDROCHLORIDE 1mg Vial
Box 5s Manufactured in: China
FDA Reg No: DR-XY45774
Valid until 2 FEB 2022

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 SUBLIFEN
2mg Vial,
Box 5s
FDA Reg No: DR-XY45773
Valid until 2 FEB 2022
ZOLPIDEM * DACTIVE I/D: Zydus Healthcare
10mg Tablet Philippines, Inc
Blister 100s
FDA Reg No: DRP-7184 Manfuactured In: India
Valid Until 19 JAN 2021
* SITINOX I/D: Sahar Int’l Trading, Inc.,
10mg, Film-Coated Tablet Paranaque City
Blister 10s, Box 10s
FDA Reg. No.: DR-39241 M: China
Valid Until 30 MAR 2021
* STILNOX I: Sanofi-Aventis Phils., Inc.,
10mg, Film-Coated Tablet Makati City
Blister 15s, Box 30s
BFAD Reg. No.: DRP-014 M: Sanofi Winthrop Industrie,
Valid Until: 13 APRIL 2019 France
RENEWED WITH OR# 1097211
DATED MARCH 12, 2019
Validity is extended for 1 yr 13 APRIL 2020
under RENEWAL DTN:20190201104557
* ZOLDEM M: Amherst Laboratories, Inc
10mg, film coated tablet
Blister 10s, Box 30s Trader: UNILAB, Inc
BFAD Reg. No.: DR-XY32230
Valid until 16 NOV 2020

ND 09/30/2019

Page 14 / 15/nmdSeptember30,2019
 LIST OF DRUG PREPARATIONS CONTAINING PHILIPPINE TABLE 1 CONTROLLED CHEMICALS

DISPENSING / PRESCRIBING / RECORDING / REPORTING:

Subject to Food and Drugs Administration (FDA) rules and regulations.

LICENSE REQUIRED:
Manufacturer / Repacker S5-C License
Importer S5-I License
Exporter S5-E License

Drug Preparation Brand Name, Importer (I) / Distributor (D) /

(Active Ingredient) Dosage Form & Strength / CPR Manufacturer (M)

***ERGOMETRINE / Various Pharmaceutical Drug Various Entities

ERGONOVINE Preparations

***ERGOTAMINE Various Pharmaceutical Drug Various Entities

Preparations

***NOREPHEDRINE / Various Pharmaceutical Drug Various Entities

PHENYLPROPANOLAMINE Preparations

LEGEND:

* All oral forms of Philippine Schedule 4 and 5 Dangerous Drugs are:

1. Exempted from DOH Special Prescription Form for Dangerous Drugs (SPFDD) per Section 4 (4a)
Board Regulation No. 1 Series 2014. To be prescribed in an ordinary prescription form in triplicate
copies containing the standard information of a prescription Section 31 (3) Board Regulation No. 1
Series 2014.
2. Exempted from PDEA Form 1-0A (Local Order Permit) for transactions between wholesaler and
retail drugstore or hospital pharmacy.

** Exempted from DOH Special Prescription for Dangerous Drugs (SPFDD). To be prescribed in ordinary
prescription form in triplicate copies, bearing the current S2 License of the prescribing medical practitioner.
Section 4 (2b) Board Regulation 1 Series 2014.

*** Only importer, exporter and manufacturer will require registration of license. For importation of a finished
product that exceeds the equivalent quantities of 0.010grams ergometrine / ergonovine, 0.020grams
ergotamine and / or 2.5Kg norephedrine per importation, an import permit shall be required. Each import or
export transaction shall be reported to PDEA not later than five (5) working days before date of importation
or exportation of the shipment.
Section 4 (5) Board Regulation 1 Series 2014.

ITEMS IN RED FONT – FOR REVALIDATION / AWAITING SUBMISSION OF UPDATED CPR

Noted by:

DIR II AGNES D. MANDAP

ACTING DIRECTOR, COMPLIANCE SERVICE

Page 15 / 15/nmdSeptember30,2019