NDC 51660-071

Guaifenesin and Pseudoephedrine Hydrochloride

Guaifenesin And Pseudoephedrine Hydrochloride

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

Product ID51660-071_6c98216c-cd98-4fbf-a940-5cc116d694b1
NDC51660-071
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Pseudoephedrine Hydrochloride
Generic NameGuaifenesin And Pseudoephedrine Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-11-15
Marketing CategoryNDA / NDA
Application NumberNDA021585
Labeler NameOHM LABORATORIES INC
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength600 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51660-071-18

1 BLISTER PACK in 1 CARTON (51660-071-18) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2017-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51660-071-36 [51660007136]

Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021585
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-10

NDC 51660-071-18 [51660007118]

Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021585
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-10

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:400252ae-fe27-4f82-87f3-ead7eff335de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1305603
  • NDC Crossover Matching brand name "Guaifenesin and Pseudoephedrine Hydrochloride" or generic name "Guaifenesin And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0077Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine Hydrochloride
    41415-994Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine Hydrochloride
    51660-071Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine Hydrochloride
    62011-0475Guaifenesin and Pseudoephedrine HydrochlorideGuaifenesin and Pseudoephedrine Hydrochloride
    66992-281Entex TGuaifenesin and Pseudoephedrine Hydrochloride
    79903-125equate mucus dguaifenesin and pseudoephedrine hydrochloride
    0363-9930Guaifenesin DGuaifenesin and Pseudoephedrine Hydrochloride
    0536-1333Guaifenesin DGuaifenesin and Pseudoephedrine Hydrochloride
    51316-993Guaifenesin DGuaifenesin and Pseudoephedrine Hydrochloride
    70000-0580Guaifenesin DGuaifenesin and Pseudoephedrine Hydrochloride
    58605-101MaxifedGUAIFENESIN and Pseudoephedrine Hydrochloride
    51316-970MAXIMUM STRENGTH Mucus Dguaifenesin and pseudoephedrine hydrochloride
    50090-1075Mucinex DGuaifenesin and Pseudoephedrine Hydrochloride
    50090-1076Mucinex DGuaifenesin and Pseudoephedrine Hydrochloride
    63824-041Mucinex DGuaifenesin and Pseudoephedrine Hydrochloride
    63824-057Mucinex DGuaifenesin and Pseudoephedrine Hydrochloride
    68258-3035Mucinex DGuaifenesin and Pseudoephedrine Hydrochloride
    70518-0523Mucinex DGuaifenesin and Pseudoephedrine Hydrochloride
    0536-1137Mucus Relief DGuaifenesin and Pseudoephedrine Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.