NDC 70518-0418

PROMETHAZINE DM

Dextromethorphan Hydrobromide And Promethazine Hydrochloride

PROMETHAZINE DM is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

Product ID70518-0418_84f6a71f-5f81-cdb0-e053-2a91aa0a6209
NDC70518-0418
Product TypeHuman Prescription Drug
Proprietary NamePROMETHAZINE DM
Generic NameDextromethorphan Hydrobromide And Promethazine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA040649
Labeler NameREMEDYREPACK INC.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength15 mg/5mL; mg/5mL
Pharm ClassesUncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0418-0

118 mL in 1 BOTTLE (70518-0418-0)
Marketing Start Date2017-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0418-0 [70518041800]

PROMETHAZINE DM SOLUTION
Marketing CategoryANDA
Application NumberANDA040649
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-05
Marketing End Date2020-04-13

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

OpenFDA Data

SPL SET ID:7c99f10f-6982-4c08-b4d3-d90c4e8aaa2e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991528

    • Pharmacological Class

    • Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
    • Sigma-1 Agonist [EPC]
    • Uncompetitive NMDA Receptor Antagonists [MoA]
    • Sigma-1 Receptor Agonists [MoA]
    • Phenothiazine [EPC]
    • Phenothiazines [CS]

    NDC Crossover Matching brand name "PROMETHAZINE DM" or generic name "Dextromethorphan Hydrobromide And Promethazine Hydrochloride"

    NDCBrand NameGeneric Name
    0603-1586PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    17856-1586PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    33261-732PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    50090-0225PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    50090-4125PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    50436-1867PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    53002-4260PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    63187-272PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    68071-1643PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    68788-9097PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    70518-0418PROMETHAZINE DMDextromethorphan Hydrobromide and Promethazine Hydrochloride
    17856-0604Dextromethorphan Hydrobromide and Promethazine HydrochlorideDextromethorphan Hydrobromide and Promethazine Hydrochloride
    63187-355Dextromethorphan Hydrobromide and Promethazine HydrochlorideDextromethorphan Hydrobromide and Promethazine Hydrochloride
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