NDC 65162-038

Guaifenesin and Dextromethorphan HBr

Guaifenesin And Dextromethorphan Hbr

Guaifenesin and Dextromethorphan HBr is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID65162-038_2f1a0641-dd6e-4cce-9a6b-6326d6002155
NDC65162-038
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Dextromethorphan HBr
Generic NameGuaifenesin And Dextromethorphan Hbr
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA209692
Labeler NameAmneal Pharmaceuticals LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength30 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 65162-038-03

1 BOTTLE in 1 CARTON (65162-038-03) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-038-06 [65162003806]

Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209692
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 65162-038-03 [65162003803]

Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209692
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 65162-038-17 [65162003817]

Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209692
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:5760a828-1c28-4272-a7b7-ac98466aa294
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298324
    • UPC Code
  • 0365162038170
  • 0365162038064

    • NDC Crossover Matching brand name "Guaifenesin and Dextromethorphan HBr" or generic name "Guaifenesin And Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    30142-948GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBr
    30142-963GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBr
    41163-030Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    41415-998Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan Hbr
    41415-999Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    68788-7317Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    58602-715Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    58602-825Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    58602-824Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    65162-039Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    65162-038Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    79395-002Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    58602-849Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
    0363-0510Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBr
    41163-985Maximum Strength Mucus-DMGuaifenesin and Dextromethorphan HBr
    46122-420Mucus DMGuaifenesin and Dextromethorphan HBr
    11822-5330Mucus Relief Cough and Congestion DMGuaifenesin and Dextromethorphan HBr
    17714-150Mucus Relief Cough and Congestion DMGuaifenesin and Dextromethorphan HBr
    0363-0474Mucus Relief DMGuaifenesin and Dextromethorphan HBr
    0363-0533Mucus Relief DMGuaifenesin and Dextromethorphan HBr
    11673-611mucus relief DMGuaifenesin and Dextromethorphan HBr
    21130-997MUCUS RELIEF DMGuaifenesin and Dextromethorphan HBr
    21130-989Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBr
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