NDC 70000-0302

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 ID70000-0302_45763afa-56cd-42ee-9658-6aa1cba51710
NDC70000-0302
Product TypeHuman Otc Drug
Proprietary NameLeader Cough DM
Generic NameDextromethorphan Polistirex
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-06-06
Marketing CategoryANDA / ANDA
Application NumberANDA091135
Labeler NameCardinal Health
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0302-1

1 BOTTLE in 1 CARTON (70000-0302-1) > 89 mL in 1 BOTTLE
Marketing Start Date2017-06-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0302-1 [70000030201]

Leader Cough DM SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091135
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-06-06

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

OpenFDA Data

SPL SET ID:a07b70d0-3842-4ea6-abb4-95b4638d5e55
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373045
  • Medicade Reported Pricing

    70000030201 COUGH DM ER 30 MG/5 ML SUSP

    Pricing Unit: ML | Drug Type:

    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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