NDC 76457-004

SIMPEX Guaifenesin

Guaifenesin

SIMPEX Guaifenesin is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Simpex Pharma Pvt. Ltd. The primary component is Guaifenesin.

Product ID76457-004_7d870204-c1ad-fa24-e053-2a91aa0a2be6
NDC76457-004
Product TypeHuman Otc Drug
Proprietary NameSIMPEX Guaifenesin
Generic NameGuaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-02-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSimpex Pharma Pvt. Ltd
Substance NameGUAIFENESIN
Active Ingredient Strength400 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76457-004-00

100 TABLET in 1 CARTON (76457-004-00)
Marketing Start Date2018-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76457-004-00 [76457000400]

SIMPEX Guaifenesin TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-02-09

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:1594f9d6-0c48-42bf-b76b-d621f215179a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359601
    • UPC Code
  • 8901252955396

    • NDC Crossover Matching brand name "SIMPEX Guaifenesin" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    76457-004SIMPEX GuaifenesinSIMPEX Guaifenesin
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin
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