NDC 63868-390

Guaifenesin Extended Release

Guaifenesin

Guaifenesin Extended Release is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Chain Drug Marketing Association Inc. The primary component is Guaifenesin.

Product ID63868-390_469be0ad-f587-4e64-b556-6e102ec5abf1
NDC63868-390
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin Extended Release
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-10-15
Marketing CategoryNDA / NDA
Application NumberNDA021282
Labeler NameCHAIN DRUG MARKETING ASSOCIATION INC
Substance NameGUAIFENESIN
Active Ingredient Strength1200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63868-390-28

2 BLISTER PACK in 1 CARTON (63868-390-28) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2017-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63868-390-28 [63868039028]

Guaifenesin Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021282
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-10

NDC 63868-390-14 [63868039014]

Guaifenesin Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021282
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-12-10

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN1200 mg/1

OpenFDA Data

SPL SET ID:fa05cfe6-5019-4c1b-8fe0-c2c0e278e89e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310621

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

    NDCBrand NameGeneric Name
    68196-072Guaifenesin Extended ReleaseGuaifenesin Extended Release
    69842-016Guaifenesin Extended ReleaseGuaifenesin Extended Release
    45802-325Guaifenesin Extended ReleaseGuaifenesin Extended Release
    49035-074Guaifenesin Extended ReleaseGuaifenesin Extended Release
    51660-072Guaifenesin Extended ReleaseGuaifenesin Extended Release
    63868-390Guaifenesin Extended ReleaseGuaifenesin Extended Release
    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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