NDC 58602-824

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 Aurohealth Llc. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

Product ID58602-824_029ee6fb-df76-4df6-b717-70005d5708da
NDC58602-824
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Dextromethorphan HBr
Generic NameGuaifenesin And Dextromethorphan Hbr
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA206941
Labeler NameAurohealth LLC
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength600 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58602-824-08

4 BLISTER PACK in 1 CARTON (58602-824-08) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2017-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-824-67 [58602082467]

Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206941
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-17

NDC 58602-824-08 [58602082408]

Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206941
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-17

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:029ee6fb-df76-4df6-b717-70005d5708da
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298324
    • UPC Code
  • 0358602824679

    • 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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