NDC 53345-028

Dextromethorphan HBr 15 mg

Dextromethorphan Hbr

Dextromethorphan HBr 15 mg is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd.. The primary component is Dextromethorphan Hydrobromide.

Product ID53345-028_43b370cb-1096-4e64-ac31-7e41046a48b3
NDC53345-028
Product TypeHuman Otc Drug
Proprietary NameDextromethorphan HBr 15 mg
Generic NameDextromethorphan Hbr
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2014-12-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength15 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-028-01

1 BAG in 1 BOX (53345-028-01) > 12000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2014-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-028-01 [53345002801]

Dextromethorphan HBr 15 mg CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-12-10

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:ffc7e1e2-b664-461b-963d-764bad2f983f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1090487
  • NDC Crossover Matching brand name "Dextromethorphan HBr 15 mg" or generic name "Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    53345-011Dextromethorphan HBr 15 mgDextromethorphan HBr 15 mg
    53345-028Dextromethorphan HBr 15 mgDextromethorphan HBr 15 mg
    21130-383Adult Cough Relief DMDextromethorphan HBr
    0363-0500CoughDextromethorphan HBr
    15127-661Cough ControlDextromethorphan HBr
    0363-8990Cough ReliefDEXTROMETHORPHAN HBr
    15127-309Cough ReliefDextromethorphan HBr
    24385-262Cough ReliefDextromethorphan HBr
    24385-263Cough ReliefDextromethorphan HBr
    33992-0666Cough ReliefDextromethorphan HBr
    36800-454Cough ReliefDextromethorphan HBr
    36800-509Cough ReliefDextromethorphan HBr
    0536-1323Dextromethorphan HBrDextromethorphan HBr
    0536-1334Dextromethorphan HBr 15 mg Liquid GelsDextromethorphan HBr
    0395-9126Father Johns MedicineDextromethorphan HBr
    0536-1068Robafen CoughDextromethorphan HBr
    0031-8741ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELSdextromethorphan HBr
    21130-635Signature Care Daytime CoughDextromethorphan HBr
    0363-6610Wal-TussinDextromethorphan HBr

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