NDC 12634-909

Promethazine Hydrochloride and Codeine Phosphate

Promethazine Hydrochloride And Codeine Phosphate

Promethazine Hydrochloride and Codeine Phosphate is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Apotheca Inc. The primary component is Codeine Phosphate; Promethazine Hydrochloride.

Product ID12634-909_49d71d3b-fb89-5738-e054-00144ff8d46c
NDC12634-909
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride and Codeine Phosphate
Generic NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date1997-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA040151
Labeler NameApotheca Inc
Substance NameCODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12634-909-06

178 mL in 1 BOTTLE (12634-909-06)
Marketing Start Date2017-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-909-02 [12634090902]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-01
Inactivation Date2020-01-31

NDC 12634-909-08 [12634090908]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-01
Inactivation Date2020-01-31

NDC 12634-909-04 [12634090904]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-01
Inactivation Date2020-01-31

NDC 12634-909-32 [12634090932]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-01
Inactivation Date2020-01-31

NDC 12634-909-28 [12634090928]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-01
Inactivation Date2020-01-31

NDC 12634-909-16 [12634090916]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-01
Inactivation Date2020-01-31

NDC 12634-909-06 [12634090906]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE10 mg/5mL

OpenFDA Data

SPL SET ID:47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991486

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]
    • Phenothiazine [EPC]
    • Phenothiazines [CS]

    NDC Crossover Matching brand name "Promethazine Hydrochloride and Codeine Phosphate" or generic name "Promethazine Hydrochloride And Codeine Phosphate"

    NDCBrand NameGeneric Name
    0121-0547PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
    12634-907promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphate
    12634-909Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    17856-0065Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    17856-0139Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    17856-0804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    27808-065Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    50383-804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    63187-595promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphate
    70408-185promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphate
    70752-139Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    42254-140Prometh with CodeinePromethazine Hydrochloride and Codeine Phosphate
    0121-0928Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    0603-1585Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    17856-0605Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    17856-1585Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    21695-336Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    33261-391Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    49999-152Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    50090-4127Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    50436-1029Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    52959-118PROMETHAZINE WITH CODEINEPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
    53002-3270Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    60432-606Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    63187-271Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    67296-0516Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    68071-1606Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    68071-4037Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    68788-9895Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    70166-555Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
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