NDC 70518-0011

Guaifenesin and pseudoephedrine hydrochloride Extended Release

Guaifenesin, Pseudoephedrine Hydrochloride

Guaifenesin and pseudoephedrine hydrochloride Extended Release is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID70518-0011_41daf24d-4a93-0f9d-e054-00144ff8d46c
NDC70518-0011
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and pseudoephedrine hydrochloride Extended Release
Generic NameGuaifenesin, Pseudoephedrine Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA091071
Labeler NameREMEDYREPACK INC.
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength600 mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 70518-0011-0

18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-0011-0)
Marketing Start Date2016-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0011-0 [70518001100]

Guaifenesin and pseudoephedrine hydrochloride Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091071
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-11-21
Marketing End Date2019-08-13
Inactivation Date2020-01-31
Reactivation Date2020-03-25

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:6e91061b-3e87-49e0-9deb-3644394cfd93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1305603

    • NDC Crossover Matching brand name "Guaifenesin and pseudoephedrine hydrochloride Extended Release" or generic name "Guaifenesin, Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    45802-230Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloride
    63187-960Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloride
    70518-0011Guaifenesin and pseudoephedrine hydrochloride Extended ReleaseGuaifenesin, pseudoephedrine hydrochloride
    49035-729equate mucus dguaifenesin, pseudoephedrine hydrochloride
    49035-792equate mucus dguaifenesin, pseudoephedrine hydrochloride
    46122-239Good Neighbor Pharmacy Mucus DGuaifenesin, pseudoephedrine hydrochloride
    69256-144Harris Teeter Mucus Relief DGuaifenesin, pseudoephedrine hydrochloride
    62011-0259Health Mart mucus relief dGuaifenesin, pseudoephedrine hydrochloride
    55316-144healthy accents mucus relief DGuaifenesin, pseudoephedrine hydrochloride
    70000-0004leader mucus relief dGuaifenesin, pseudoephedrine hydrochloride
    0113-2002Mucus DGuaifenesin, pseudoephedrine hydrochloride
    30142-144Mucus DGuaifenesin, pseudoephedrine hydrochloride
    41250-144Mucus DGuaifenesin, pseudoephedrine hydrochloride
    59779-825Mucus DGuaifenesin, pseudoephedrine hydrochloride
    56062-144Mucus D ERGuaifenesin, pseudoephedrine hydrochloride
    0363-0144Mucus Relief DGuaifenesin, pseudoephedrine hydrochloride
    11822-0144mucus relief dGuaifenesin, pseudoephedrine hydrochloride
    37808-446Mucus Relief DGuaifenesin, pseudoephedrine hydrochloride
    37808-777mucus relief dGuaifenesin, pseudoephedrine hydrochloride
    0536-1205rugby mucus relief dGuaifenesin, pseudoephedrine hydrochloride
    49348-113Sunmark mucus relief dGuaifenesin, pseudoephedrine hydrochloride
    36800-144TopCare Mucus DGuaifenesin, pseudoephedrine hydrochloride
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