NDC 17856-1585

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

Product ID17856-1585_482db043-19a2-486d-9dee-63a1fe4d49fc
NDC17856-1585
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 NameAtlantic Biologicals Corps
Substance NamePROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active Ingredient Strength6 mg/5mL; mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS]
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-1585-5

5 mL in 1 CUP (17856-1585-5)
Marketing Start Date2006-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-1585-5 [17856158505]

Promethazine with Codeine SYRUP
Marketing CategoryANDA
Application NumberANDA040650
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-01-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:4e0d550e-6281-48ce-819f-ca37fcca53e0
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 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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