NDC 63187-355

Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Dextromethorphan Hydrobromide And Promethazine Hydrochloride

Dextromethorphan Hydrobromide and Promethazine Hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

Product ID63187-355_237dfeed-9ff8-4ae1-81fd-1322cf252599
NDC63187-355
Product TypeHuman Prescription Drug
Proprietary NameDextromethorphan Hydrobromide and Promethazine Hydrochloride
Generic NameDextromethorphan Hydrobromide And Promethazine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date1985-01-04
Marketing CategoryANDA / ANDA
Application NumberANDA088864
Labeler NameProficient Rx LP
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 63187-355-04

118 mL in 1 BOTTLE, PLASTIC (63187-355-04)
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-355-04 [63187035504]

Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA088864
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-01

NDC 63187-355-16 [63187035516]

Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA088864
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-12-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

OpenFDA Data

SPL SET ID:c155b478-c04d-47e5-891b-408d09a5acf3
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]
    • 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 "Dextromethorphan Hydrobromide and Promethazine Hydrochloride" or generic name "Dextromethorphan Hydrobromide And Promethazine Hydrochloride"

    NDCBrand NameGeneric Name
    17856-0604Dextromethorphan Hydrobromide and Promethazine HydrochlorideDextromethorphan Hydrobromide and Promethazine Hydrochloride
    63187-355Dextromethorphan Hydrobromide and Promethazine HydrochlorideDextromethorphan Hydrobromide and Promethazine Hydrochloride
    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
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