NDC 0615-7712

Guaifenesin Extended Release Extended Release

Guaifenesin

Guaifenesin Extended Release Extended Release is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Guaifenesin.

Product ID0615-7712_3e214e7d-8263-4eb7-8b2a-a8937e80fb24
NDC0615-7712
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin Extended Release Extended Release
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA078912
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameGUAIFENESIN
Active Ingredient Strength600 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-7712-39

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7712-39)
Marketing Start Date2012-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7712-39 [00615771239]

Guaifenesin Extended Release Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078912
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-03-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:f3f7802e-ee96-4462-a7e6-bb087d0fdcf5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636522

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

    NDCBrand NameGeneric Name
    0615-7712Guaifenesin Extended Release Extended ReleaseGuaifenesin Extended Release 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
    © 2026 FDA.report
    This site is not affiliated with or endorsed by the FDA.