NDC 52083-630

PECGEN DMX

Dextromethorphan Hbr, Guaifenesin

PECGEN DMX is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID52083-630_39b9140f-3d5f-47e8-87db-3985a66681c8
NDC52083-630
Product TypeHuman Otc Drug
Proprietary NamePECGEN DMX
Generic NameDextromethorphan Hbr, Guaifenesin
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-04-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKRAMER NOVIS
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength10 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-630-16

474 mL in 1 BOTTLE, PLASTIC (52083-630-16)
Marketing Start Date2015-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-630-16 [52083063016]

PECGEN DMX SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-04-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:a627824c-5e3d-4672-a047-6c801b50b432
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1441364
    • UPC Code
  • 0352083630163

    • NDC Crossover Matching brand name "PECGEN DMX" or generic name "Dextromethorphan Hbr, Guaifenesin"

    NDCBrand NameGeneric Name
    52083-630PECGEN DMXPECGEN DMX
    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
    0904-6464robafenDextromethorphan 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.