NDC 17856-0804

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 Atlantic Biologicals Corps. The primary component is Promethazine Hydrochloride; Codeine Phosphate.

Product ID17856-0804_bac94880-a702-43e3-ba7e-0c62928a0c31
NDC17856-0804
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 NameAtlantic Biologicals Corps
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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0804-5

5 mL in 1 CUP (17856-0804-5)
Marketing Start Date1997-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0804-5 [17856080405]

Promethazine Hydrochloride and Codeine Phosphate SYRUP
Marketing CategoryANDA
Application NumberANDA040151
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-08-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:5eafbdbe-58f1-4f2c-a12f-7a5d924e5fff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991486

    • Pharmacological Class

    • 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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