NDC 49781-138

leader cough dm

Dextromethorphan Polistirex

leader cough dm is a Oral Suspension, Extended Release in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Dextromethorphan Hydrobromide.

Product ID49781-138_4e74ed46-1f10-4343-b063-cbedd3d1ca39
NDC49781-138
Product TypeHuman Otc Drug
Proprietary Nameleader cough dm
Generic NameDextromethorphan Polistirex
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-04-03
Marketing End Date2019-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA091135
Labeler NameCardinal Health
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagN

Packaging

NDC 49781-138-03

1 BOTTLE in 1 CARTON (49781-138-03) > 89 mL in 1 BOTTLE
Marketing Start Date2015-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49781-138-03 [49781013803]

leader cough dm SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091135
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-03
Marketing End Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

OpenFDA Data

SPL SET ID:f534cedf-40f2-4653-b3eb-92caeb3725ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373045
  • NDC Crossover Matching brand name "leader cough dm" or generic name "Dextromethorphan Polistirex"

    NDCBrand NameGeneric Name
    70000-0187Leader Cough DMLeader Cough DM
    70000-0302Leader Cough DMLeader Cough DM
    37205-697leader cough dmleader cough dm
    49781-138leader cough dmleader cough dm
    0113-7384basic care cough DMdextromethorphan polistirex
    0363-0899childrens cough dmDextromethorphan polistirex
    0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0363-0384Cough DMdextromethorphan polistirex
    0363-0494Cough DMdextromethorphan polistirex
    0363-0958Cough DMdextromethorphan polistirex
    0904-6312cough dmdextromethorphan polistirex
    11822-0384Cough DMdextromethorphan polistirex
    11822-0494Cough DMdextromethorphan polistirex
    0113-0384good sense cough dmdextromethorphan polistirex
    0113-0958Good Sense Cough DMdextromethorphan polistirex
    0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    11673-114up and up 12 hour cough reliefdextromethorphan polistirex

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