GUIDE TO MEDICAL / PARAMEDICAL PRACTITIONERS LIST OF ...

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 (Yellow Rx). 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 Retail Dealer of DDPs Wholesaler Dealer of DDPs Manufacturer / Repacker of DDPs Importer of DDPs Exporter of DDPs

S2 License S3 License S4 License S5-C License S5-I License S5-E License

Dangerous Drug (Active Ingredient)

ALPRAZOLAM

Brand Name, Dosage Form & Strength / CPR * ALTROX 250mcg Tablet Blister 10s, Box 100s

FDA Reg. No.: DRP 3132 Valid until 11 APRIL 2019

Importer (I) / Distributor (D) / Manufacturer (M) I/D:Torrent Pharmaceuticals, Ltd

Manufactured in: India

* ALTROX 500mcg Tablet Blister 10s, Box 100s FDA Reg. No.: DRP 3180 Valid until 26 JUNE 2018

I/D:Torrent Pharmaceuticals, Ltd

Manufactured in: India

* ZOLDAC 250mcg Tablet Blister 10s, Box of 30s FDA Reg. No.: DX- XY 45450 Valid until 16 JUN 2021

I/D: Zydus Philippines, Inc Manufactured in: India

* ZOLDAC 500mcg Tablet Blister 10s, Box 30s FDA Reg. No.: DR-XY 45396 Valid until 23 MAY 2021

I/D: Zydus Philippines, Inc Manufactured in: India

* ZOLGEN 500mcg Tablet Blister 10s, Box 100s FDA Reg No.: DR-XY 39552 Valid until 01 JUNE 2018

M: Lloyd Laboratories Inc

T: Innogen Pharmaceuticals, Inc

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BROMAZEPAM

* XANOR 250mcg Tablet Blister 10s Box 100s FDA Reg. No.: DRP 2146 Valid until 20 NOV 2018

I / D: Pfizer Manufactured in: Italy

* 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 11 AUG 2019

* XANOR 1mg Tablet Blister 10s Box 100s FDA Reg. No.: DR-XY16774 Valid until 21 MAR 2020

* AXAL 250mcg Tablet Blister 10s, Box 30s FDA Reg. No.: DR-XY 38992 Valid until 27 JAN 2021

I/D: Sahar International Trading, Paranaque, City

Manufactured in: Pakistan

* 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

* SERELAM 250mcg Tablet Blister 10s, Box 100s FDA Reg No. DRP-5103 Valid until 12 APR 2019

I/D: Ambica Int'l Trading Corp, Pque

Manufactured in: Bangladesh

* LEXOTAN 1.5mg Tablet Blister 10s, Box 100s FDA Reg No: DR-XY40440 Valid until 22 DEC 2021

I: Roche Phils., Inc., Taguig City

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BUPRENORPHINE CLONAZEPAM

** NORSPAN 5mg Transdermal Patch Box 2s

FDA Reg. No. DR-XY35292 Valid until 24 NOV 2020

I/D:

Mundipharma

DistributionGmbH (Philippine

Branch)

M: 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 20mg (35mcg/h) Transdermal Patch Box 1s, 2s, 4s

FDA Reg. No: DR-XY 46026 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 500mcg (0.5mg) Tablet Blister 10s, Box 20S & 100s FDA Reg No: DRP-2810 Valid until 29 AUG 2018

* CLONOTRIL-2 2mg Tablet Blister 10s, Box 20s & 100s FDA Reg No: DRP-2809 Valid until 02 SEP 2018

* EPILINE 2 2mg Tablet Blister 10s

FDA Reg No: DR-XY 44549 Valid until 27 MAY 2020

* LUNAZ 500mcg Tablet Blister 10s, Box 100s FDA Reg No: DR-XY42943 Valid until 13 NOV 2018

* LUNAZ 2mg Tablet Blister 10s, Box 50s FDA Reg No: DR-XY42944 Valid until 13 NOV 2018

* RIVOTRIL 2mg Tablet Bottle 100s FDA Reg. No. DR-XY37012 Valid until 19 NOV 2019

I/D:

Mundipharma

Distribution

GmbH

(Philippine Branch)

I/D: Torrent Pharma Phils Inc M: Torrent, India

I/D: Zydus Healthcare Philippines, Inc,

I/D: Euro Generics Intl Phils Inc. M: Bangladesh

I: Roche Phils., Inc, Makati City D: Zuellig Pharma Corp., Makati City Manufactured in: Spain

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CLORAZEPATE DIPOTASSIUM DIAZEPAM

* TRANXENE 5mg Capsules Blister 10s, Box 30s FDA Reg. No. DR-X1254 Valid until 14 OCT 2022

ANXIOL 5mg/mL, 2ml (10mg/ 2ml) Ampule Box 10s

FDA Reg. No. DR-XY29833 Valid until 9 AUG 2022

I: Sanofi-Aventis, Phil

Manufacturer: Sanofi Aventis, Spain

Repacker:Hizon Laboratories I / D: Endure Medical Inc., Pasig City

Manufactured in: Taiwan

ANXOL 5mg/ml (10mg/2ml) IM/IV Ampule Box 10s

FDA Reg No DRP-4175 Valid until 16 DEC 2019

I/D: Ambica Intl Trading Corp, Pque

M: India

LORCAM 5mg/mL, 2mL Ampule Box 50s

FDA Reg. No. DR-XY22760-B Valid until 20 NOV 2018

TRANKIL 5mg/mL, 2ml Ampule Box 10s

FDA Reg. No. DR-XY29949 Valid until 03 SEP 2019

I / D: Lordla Pharma Sales, Quezon City

M: Thailand

I/D: Duopharma Trade Phils

M: Rotexmedica, GmBH, Germany

VALIUM 5mg/mL, 2ml Ampule Box 10s

FDA Reg No. DR-6298 Valid until 14 APR 2018

* VALIUM 5mg Tablet Blister 25s, Box 100s FDA Reg. No. DR-XY37749 valid until 30 JAN 2020

I: Roche Phils., Inc., Taguig City

D: Zuellig Pharma Corporation, Pque City

Manufactured in: Spain

* VALIUM 10mg Tablet Blister 25s, Box 100s FDA Reg. No. DR-XY37748 Valid until 7 APR 2021

VALZEPAM 5mg/mL, 2mL Ampule Box 50s

FDA Reg. No. DR-XY27221 Valid until 21 Dec 2021

I/D: Phil Pharmawealth, Inc Manufactured in: Thailand

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EPHEDRINE FENTANYL

FENTANYL CITRATE

FEDRIN 30mg/mL, 1mL Ampule Box 5's

FDA Reg No. DR-XY41068 Valid until 18 JULY 2022

EPHEDRINE SULFATE 50mg/mL, 1mL Ampule Box 100s

FDA Reg No. DR-4468 Valid until 21 FEB 2023 DUROGESIC D-TRANS 12mcg/hr Transdermal Patch Box 5s FDA Reg No. DR-XY33326 Valid until 29 DEC 2020 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 12.5mcg/hr Transdermal Patch Box 5s FDA Reg No. DRP-4099 Valid until 14 NOV 2022 FENDERMAL 25mcg/hr Transdermal Patch Box 5s FDA Reg No. DRP-4112 Valid until 22 NOV 2022

I/D: Sahar International M: Pakistan M: Hizon Laboratories, Inc

Importer: Johnson & Johnson Distributor: Zuellig Pharma Corp Manufactured in: Belgium

I: Sandoz Phils Corp, Makati M: Germany

FENDERMAL 50mcg/hr Transdermal Patch Box 5s

FDA Reg No. DRP-4111 Valid until 22 NOV 2022

ABSTRAL 100mcg Sublingual Tablet Blister 10s, Box 10s & 30s

FDA Reg No. DR-XY45371 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

Trader: A. Menarini Philippines, Inc

Manufactured in: UK

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FENTANYL CITRATE

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

FENTANYL CITRATE 50mcg/mL, 2mL, Ampule 10's

FDA Reg No. DR-XY17752 Valid until 07 NOV 2022

FENTANYL CITRATE 50mcg/ml, 2mL & 10mL Ampule 5's

FDA Reg No. DR-XY32871 Valid until 06 FEB 2022

FENTYN 25mcg/hr Transdermal Patch Sachet, Box 5s

FDA Reg No. DRP-4112-01 valid until 22 NOV 2022

FENTYN 50mcg/hr Transdermal Patch Sachet, Box 5s

FDA Reg No. DRP-4111-01 valid until 22 NOV 2022

FRESANYL 50mcg/ml (100mcg/ 2ml) Type 1 amber glass 2 ml ampule 10s Type 1 amber glass 10 ml ampule 5s

FDA Reg No. DR-XY45908 Valid until 24 MAY 2022

I: Pfizer M: in USA

I/D: Pfizer M: in Germany

Importer: Sandoz Philippines

Corporation

Distributor:

United

Laboratories

Manufactured in: Germany

Importer: Sandoz Philippines

Corporation

Distributor:

United

Laboratories

Manufactured in: Germany

Importer/Distributor:

Fresenius Kabi Philippines

Manufactured in: Africa

MATRIFEN 12mcg/hr Transdermal Patch Box 5's

FDA Reg. No. DR-XY43161 Valid until : 10 FEB 2019

MATRIFEN 25mcg/hr Transdermal Patch Box 5's

FDA Reg. No. DR-XY43162 Valid until : 10 FEB 2019

MATRIFEN 50mcg/hr Transdermal Patch Box 5's

FDA Reg. No. DR-XY43163 Valid until : 10 FEB 2019

I: Nycomed Philippines Manufactured in: Denmark

I: Nycomed Philippines Manufactured in: Denmark

I: Nycomed Philippines Manufactured in: Denmark

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FENTANYL CITRATE KETAMINE HCL*

MATRIFEN 75mcg/hr Transdermal Patch Box 5's

FDA Reg. No. DR-XY43122 Valid until : 17 MAR 2019

I: Nycomed Philippines Manufactured in: Denmark

MATRIFEN 100mcg/hr Transdermal Patch Box 5's

FDA Reg. No. DR-XY43120 Valid until : 17 MAR 2019

I: Nycomed Philippines Manufactured in: Denmark

SUBLIMAX 50mcg/mL, 2mL Ampule Box 10s

FDA Reg No. DR-XY43003 Valid until 22 NOV 2018

SUBLIMAZE 50mcg/mL, 2mL & 10mL Ampule Box 5s

FDA Reg No. DR-XY22177 Valid until 29 JULY 2018

I/D: Endure Medical Inc, Pasig

M: China

Importer: Johnson & Johnson Philippines, Inc D: ZPC, Paranaque Manufactured by: GSK, Italy

ETAMINE 50mg/mL Vial Box 1s

FDA Reg No: DR-XY41256 Valid until 19 SEPT 2018

I: Intl Apex Pharmls Inc D: Phil Pharmawealth

M: Swiss Parenterals, india

KETAMINE 50mg/ml (500mg/10ml) Vial Box 10s

FDA Reg No: DR-XY45439 Valid until 8 JUNE 2018

Importer/Distributor: Endure Medical, Inc

Manufactured in: Korea

* KETAMAX 50mg/mL, 10mL Vial Box 1's

FDA Reg No. DR-XY19615 Valid until 17 FEB 2020

I/D: Duopharma Trade Phils Manufactured in: Germany

KETAROL 50mg/mL, 10mL Vial Box 1s

FDA Reg No. DR-XY41210 Valid until 11 SEPT 2022

I/D:Surestep Pharmaceuticals Inc, Pque City

M: Pakistan

* UNIKET 50mg/mL, 10mL Vial Box 5s

FDA Reg No. DR-XY31311 Valid until 13 OCT 2018

I/D: Claris Lifesciences Phils Manufactured in India

Page 7 / 15

METHYLPHENIDATE HCL MIDAZOLAM

CONCERTA 18mg Extended Release Tablet Bottle 30s

FDA Reg No. DR-XY27940 Valid until 03 AUG 2022

I: Johnson & Johnson Phils Inc., Pque City D: Zuellig Pharma Corp, Pque City M: Puerto Rico

CONCERTA 27mg Extended Release Tablet Bottle 30s

BFAD Reg No. DR-XY30659 Valid until 22 JULY 2019

I: Johnson & Johnson Phils Inc., Pque City D: Zuellig Pharma Corp, Pque City M: Puerto Rico

CONCERTA 36mg Extended Release Tablet Bottle 30s

FDA Reg No. DR-XY27941 Valid until 03 AUG 2022

I: Johnson & Johnson Phils Inc., Pque City D: Zuellig Pharma Corp, Pque City M: Puerto Rico

RITALIN 10mg Tablet Blister 15's, Box 30s

FDA Reg No. DR-XY28528 Valid until 10 APR 2023

I: Novartis Healthcare Phils., Inc., Makati City

Manufactured in: Spain

RITALIN LA 20mg Modified Release Capsule HDPE bottle of 30s

FDA Reg No. DR-XY43804 Valid until 14 OCT 2019

I: Novartis Healthcare Phils., Inc., Makati City

Manufactured in: USA

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

DORMID 1mg/ml (5mg/5ml) Ampule, Box 10s

FDA Reg No. DR-XY44212 Valid until 15 FEB 2021

DORMID 5mg/ml (15mg/3ml) Ampule, Box 5s

FDA Reg No. DR-XY44213 Valid until 15 FEB 2021

DORMICUM 1mg/mL, 5mL (5mg/ 5ml) Ampule Box 10s

FDA Reg No: DR-XY28582 Valid until 28 APR 2018

Importer/Distributor: Endure Medical Inc

Manufactured in: Indonesia

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