NDC 33261-732

PROMETHAZINE DM

Dextromethorphan Hydrobromide And Promethazine Hydrochloride

PROMETHAZINE DM is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

Product ID33261-732_2c926159-2df1-424e-b19f-197833e3dd10
NDC33261-732
Product TypeHuman Prescription Drug
Proprietary NamePROMETHAZINE DM
Generic NameDextromethorphan Hydrobromide And Promethazine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2006-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA040649
Labeler NameAidarex Pharmaceuticals LLC
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 Through2019-12-31

Packaging

NDC 33261-732-01

118 mL in 1 BOTTLE, PLASTIC (33261-732-01)
Marketing Start Date2006-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-732-01 [33261073201]

PROMETHAZINE DM SYRUP
Marketing CategoryANDA
Application NumberANDA040649
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-02-14
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

OpenFDA Data

SPL SET ID:5024bf2c-d0f8-4838-8d93-d435bad05803
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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