NDC 58602-834

Guaifenesin and Pseudoephedrine HCl

Guaifenesin And Pseudoephedrine Hcl

Guaifenesin and Pseudoephedrine HCl 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; Pseudoephedrine Hydrochloride.

Product ID58602-834_2f622f57-4de0-44a9-a21f-c98260574f1e
NDC58602-834
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Pseudoephedrine HCl
Generic NameGuaifenesin And Pseudoephedrine Hcl
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA213203
Labeler NameAurohealth LLC
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength1200 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58602-834-77

1 BLISTER PACK in 1 CARTON (58602-834-77) > 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2020-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-834-78 [58602083478]

Guaifenesin and Pseudoephedrine HCl TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA213203
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-25

NDC 58602-834-77 [58602083477]

Guaifenesin and Pseudoephedrine HCl TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA213203
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-25

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN1200 mg/1

OpenFDA Data

SPL SET ID:2f622f57-4de0-44a9-a21f-c98260574f1e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1244675

    • NDC Crossover Matching brand name "Guaifenesin and Pseudoephedrine HCl" or generic name "Guaifenesin And Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    0363-9946Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    11822-0046Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCL
    30142-137Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    51660-057Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    51660-058Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    55111-798Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCL
    55111-799Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCL
    58602-833Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    58602-834Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    70677-0110Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCL
    79481-1002Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    49035-261Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mgGuaifenesin and Pseudoephedrine HCL
    0363-1604Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    0363-7064Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    11822-7399Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    69842-211Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    70000-0608Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    50991-212Poly-Vent IRGuaifenesin and Pseudoephedrine HCl
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