NDC 70000-0167

Leader Mucus ER Max

Guaifenesin

Leader Mucus ER Max is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Guaifenesin.

Product ID70000-0167_9534f294-4430-4448-8a06-8d1cd95e3f20
NDC70000-0167
Product TypeHuman Otc Drug
Proprietary NameLeader Mucus ER Max
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-11-17
Marketing CategoryANDA / ANDA
Application NumberANDA091009
Labeler NameCardinal Health
Substance NameGUAIFENESIN
Active Ingredient Strength1200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0167-1

1 BOTTLE in 1 CARTON (70000-0167-1) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2016-11-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0167-1 [70000016701]

Leader Mucus ER Max TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091009
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-17

NDC 70000-0167-2 [70000016702]

Leader Mucus ER Max TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091009
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN1200 mg/1

OpenFDA Data

SPL SET ID:b1088a51-b1f2-4796-8905-a3f9c761929c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310621
  • NDC Crossover Matching brand name "Leader Mucus ER Max" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    70000-0167Leader Mucus ER MaxLeader Mucus ER Max
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.