NDC 36800-392

topcare lansoprazole

Lansoprazole

topcare lansoprazole is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Lansoprazole.

Product ID36800-392_1c4169e0-0ba3-49ce-bb4a-649fd12b368e
NDC36800-392
Product TypeHuman Otc Drug
Proprietary Nametopcare lansoprazole
Generic NameLansoprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2021-07-29
Marketing CategoryANDA /
Application NumberANDA202319
Labeler NameTopco Associates LLC
Substance NameLANSOPRAZOLE
Active Ingredient Strength15 mg/1
Pharm ClassesInhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-392-01

1 BOTTLE in 1 CARTON (36800-392-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2021-07-29
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "topcare lansoprazole" or generic name "Lansoprazole"

NDCBrand NameGeneric Name
36800-117Topcare LansoprazoleTopcare Lansoprazole
36800-295topcare Lansoprazoletopcare Lansoprazole
0113-7003Basic Care LansoprazoleLansoprazole
0113-7116basic care lansoprazoleLansoprazole
0113-0116Good Sense LansoprazoleLansoprazole
0113-0117Good Sense lansoprazoleLansoprazole
0113-1114Good Sense LansoprazoleLansoprazole
0093-3008LansoprazoleLansoprazole
0093-3009LansoprazoleLansoprazole
0093-7350LansoprazoleLansoprazole
0093-7351LansoprazoleLansoprazole
0067-6286PrevacidLansoprazole
0113-6002Prevacid 24 HRlansoprazole

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.