NDC 0904-6758

robafen

Dextromethorphan Hbr, Guaifenesin

robafen is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID0904-6758_7ab9314c-ae49-4e68-8363-18a62b8e2a32
NDC0904-6758
Product TypeHuman Otc Drug
Proprietary Namerobafen
Generic NameDextromethorphan Hbr, Guaifenesin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-08-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMajor Pharmaceuticals
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength20 mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6758-16

473 mL in 1 BOTTLE (0904-6758-16)
Marketing Start Date2018-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6758-59 [00904675859]

robafen SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-08-13

NDC 0904-6758-16 [00904675816]

robafen SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-09-10

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL

OpenFDA Data

SPL SET ID:006a7a11-92b7-4522-b2f4-02e29d7b05d6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1245454
  • 996520
  • NDC Crossover Matching brand name "robafen" or generic name "Dextromethorphan Hbr, Guaifenesin"

    NDCBrand NameGeneric Name
    0904-6464robafenDextromethorphan HBr, Guaifenesin
    0904-6758robafenrobafen
    0904-6763robafenrobafen
    50090-4189robafenrobafen
    50090-4343robafenrobafen
    68788-7556robafenrobafen
    68788-7663robafenrobafen
    0113-7812basic care mucus dmdextromethorphan HBr, guaifenesin
    0031-2098Childrens Robitussin Elderberry Cough and Chest Congestion DMdextromethorphan HBr, guaifenesin
    0031-8760Childrens Robitussin Honey Cough and Chest Congestion DMdextromethorphan HBr, guaifenesin
    0363-0417Cough and Chest Congestion DMDextromethorphan HBr, Guaifenesin
    0363-0506Cough and Chest Congestion DMDextromethorphan HBr, Guaifenesin
    0113-0812good sense mucus dmdextromethorphan HBr, guaifenesin
    0113-0799Good Sense tussinDextromethorphan HBr, Guaifenesin
    0113-0578good sense tussin dmDextromethorphan HBr, Guaifenesin
    0113-0927Good Sense Tussin DM MaxDextromethorphan HBr, Guaifenesin
    0363-3380Mucus ReliefDextromethorphan HBr, Guaifenesin
    0363-0533Mucus Relief DMDextromethorphan HBr, Guaifenesin
    0363-0735Mucus Relief DMDextromethorphan HBr, Guaifenesin
    0031-2097Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMdextromethorphan HBr, guaifenesin
    0031-8756Robitussin Honey Maximum Strength Cough and Chest Congestion DMdextromethorphan hbr, guaifenesin
    0536-1184rugby coughDextromethorphan HBr, Guaifenesin
    0536-1199rugby mucus relief dmdextromethorphan HBr, guaifenesin
    0067-6089TherafluDextromethorphan HBr, Guaifenesin
    0113-0791tussin dmDextromethorphan HBr, Guaifenesin
    0363-0799wal tussinDextromethorphan HBr, Guaifenesin
    0363-0396wal tussin dmDextromethorphan HBr, Guaifenesin
    0363-0578wal tussin dmDextromethorphan HBr, Guaifenesin
    0363-0702wal tussin dm maxDextromethorphan HBr, Guaifenesin
    0363-1023wal tussin dm maxDextromethorphan HBr, Guaifenesin
    0363-0324Wal-Tussin DMDEXTROMETHORPHAN HBr, GUAIFENESIN

    Trademark Results [robafen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROBAFEN
    ROBAFEN
    77766289 3742296 Live/Registered
    Harvard Drug Group, LLC
    2009-06-23

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