NDC 12634-907

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 Promethazine Hydrochloride; Codeine Phosphate.

Product ID12634-907_477cedee-6bcf-2a34-e054-00144ff8d46c
NDC12634-907
Product TypeHuman Prescription Drug
Proprietary Namepromethazine hydrochloride and codeine phosphate
Generic NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2010-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA090180
Labeler NameApotheca Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active Ingredient Strength6 mg/5mL; mg/5mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12634-907-02

60 mL in 1 BOTTLE (12634-907-02)
Marketing Start Date2010-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-907-04 [12634090704]

promethazine hydrochloride and codeine phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA090180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17

NDC 12634-907-32 [12634090732]

promethazine hydrochloride and codeine phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA090180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17

NDC 12634-907-08 [12634090708]

promethazine hydrochloride and codeine phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA090180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17

NDC 12634-907-28 [12634090728]

promethazine hydrochloride and codeine phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA090180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17

NDC 12634-907-16 [12634090716]

promethazine hydrochloride and codeine phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA090180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17

NDC 12634-907-02 [12634090702]

promethazine hydrochloride and codeine phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA090180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17

NDC 12634-907-06 [12634090706]

promethazine hydrochloride and codeine phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA090180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-17

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:68639fd1-3fd5-4459-8018-51f136e3ed37
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991486

    • Pharmacological Class

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

    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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