NDC 21695-336

Promethazine with Codeine

Promethazine Hydrochloride And Codeine Phosphate

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

Product ID21695-336_1b182a47-6803-4b84-882e-544306ab0329
NDC21695-336
Product TypeHuman Prescription Drug
Proprietary NamePromethazine with Codeine
Generic NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2006-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA040650
Labeler NameRebel Distributors Corp
Substance NameCODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-336-16

473 mL in 1 BOTTLE (21695-336-16)
Marketing Start Date2006-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-336-04 [21695033604]

Promethazine with Codeine SYRUP
Marketing CategoryANDA
Application NumberANDA040650
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-01-31
Inactivation Date2019-09-24

NDC 21695-336-16 [21695033616]

Promethazine with Codeine SYRUP
Marketing CategoryANDA
Application NumberANDA040650
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-11-18
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE10 mg/5mL

OpenFDA Data

SPL SET ID:9408d9fa-ab74-4513-86bc-1f3d6d0dcf9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991486

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

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

    NDCBrand NameGeneric Name
    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
    42254-140Prometh with CodeinePromethazine Hydrochloride and Codeine Phosphate
    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
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