NDC 73057-381

Pharbinex-DM

Guaifenesin 400mg And Dextromethorphan Hbr 20mg

Pharbinex-DM is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Ulai Health Llc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID73057-381_d6e72920-8910-0f78-e053-2a95a90a672b
NDC73057-381
Product TypeHuman Otc Drug
Proprietary NamePharbinex-DM
Generic NameGuaifenesin 400mg And Dextromethorphan Hbr 20mg
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameUlai Health LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength20 mg/1; mg/1
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 73057-381-04

30 TABLET in 1 BOTTLE, PLASTIC (73057-381-04)
Marketing Start Date2019-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 73057-381-04 [73057038104]

Pharbinex-DM TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-18

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:af80d10e-3fb2-405a-a803-1f876b8dcd10
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1147685

    • NDC Crossover Matching brand name "Pharbinex-DM" or generic name "Guaifenesin 400mg And Dextromethorphan Hbr 20mg"

    NDCBrand NameGeneric Name
    16103-381PHARBINEX-DMGUAIFENESIN 400mg and DEXTROMETHORPHAN HBR 20MG
    73057-381Pharbinex-DMGuaifenesin 400mg and Dextromethorphan HBr 20mg
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