NDC 53041-233

Guaifenesin Extended-Release 600 mg

Guaifenesin

Guaifenesin Extended-Release 600 mg is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Guaifenesin.

Product ID53041-233_8186c3e8-1ae5-459d-8771-ad2d1ae95387
NDC53041-233
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin Extended-Release 600 mg
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA209215
Labeler NameGuardian Drug Company
Substance NameGUAIFENESIN
Active Ingredient Strength600 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53041-233-30

1 BLISTER PACK in 1 CARTON (53041-233-30) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53041-233-32 [53041023332]

Guaifenesin Extended-Release 600 mg TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209215
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 53041-233-38 [53041023338]

Guaifenesin Extended-Release 600 mg TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209215
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

NDC 53041-233-30 [53041023330]

Guaifenesin Extended-Release 600 mg TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209215
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:20f9e083-419d-429d-a570-24b312ed5d2a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636522
  • 310621

    • NDC Crossover Matching brand name "Guaifenesin Extended-Release 600 mg" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    53041-233Guaifenesin Extended-Release 600 mgGuaifenesin Extended-Release 600 mg
    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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