NDC 50383-804

Promethazine Hydrochloride and Codeine Phosphate

Promethazine Hydrochloride And Codeine Phosphate

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

Product ID50383-804_0fe754eb-ec42-4ebc-805b-ff24377b8852
NDC50383-804
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride and Codeine Phosphate
Generic NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1997-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA040151
Labeler NameAkorn
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 Through2023-12-31

Packaging

NDC 50383-804-16

473 mL in 1 BOTTLE (50383-804-16)
Marketing Start Date1997-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-804-16 [50383080416]

Promethazine Hydrochloride and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-08-26

NDC 50383-804-04 [50383080404]

Promethazine Hydrochloride and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-08-26

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE10 mg/5mL

OpenFDA Data

SPL SET ID:168951c0-773d-4f3d-9745-cc6de2063b61
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991486

    • Pharmacological Class

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

    Medicade Reported Pricing

    50383080416 PROMETHAZINE-CODEINE SYRUP

    Pricing Unit: ML | Drug Type:

    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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