NDC 68196-996

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 Sam's West Inc. The primary component is Guaifenesin.

Product ID68196-996_1cb900ed-18b4-4999-a149-0b4667abcda1
NDC68196-996
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin Extended Release
Generic NameGuaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-01-12
Marketing CategoryANDA /
Application NumberANDA209254
Labeler NameSAM'S WEST INC
Substance NameGUAIFENESIN
Active Ingredient Strength1200 mg/1
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68196-996-56

4 BLISTER PACK in 1 CARTON (68196-996-56) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2022-01-12
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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