NDC 58602-833

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 ID58602-833_559b0049-71c9-42a1-95cf-08c14930df7b
NDC58602-833
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 Strength600 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58602-833-12

1 BLISTER PACK in 1 CARTON (58602-833-12) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2020-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-833-12 [58602083312]

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

NDC 58602-833-17 [58602083317]

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
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:644dae51-7865-408c-a603-5eddffb90e53
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1305603

    • 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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