NDC 36800-627

topcare esomeprazole magnesium

Esomeprazole Magnesium

topcare esomeprazole magnesium 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 Esomeprazole Magnesium Dihydrate.

Product ID36800-627_6412cd47-7a90-4766-8721-4319b2621b7a
NDC36800-627
Product TypeHuman Otc Drug
Proprietary Nametopcare esomeprazole magnesium
Generic NameEsomeprazole Magnesium
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-03-12
Marketing CategoryANDA / ANDA
Application NumberANDA207193
Labeler NameTopco Associates LLC
Substance NameESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active Ingredient Strength20 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 36800-627-01

1 BOTTLE in 1 CARTON (36800-627-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2020-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-627-01 [36800062701]

topcare esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207193
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-12

NDC 36800-627-03 [36800062703]

topcare esomeprazole magnesium CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207193
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-12

Drug Details

Active Ingredients

IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

OpenFDA Data

SPL SET ID:86384845-0bea-490b-b04a-5770ef88b639
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 606726

    • NDC Crossover Matching brand name "topcare esomeprazole magnesium" or generic name "Esomeprazole Magnesium"

    NDCBrand NameGeneric Name
    36800-636Topcare Esomeprazole MagnesiumTopcare Esomeprazole Magnesium
    36800-627topcare esomeprazole magnesiumtopcare esomeprazole magnesium
    0093-6450Esomeprazole MagnesiumEsomeprazole Magnesium
    0093-6451Esomeprazole MagnesiumEsomeprazole Magnesium
    0186-0382Esomeprazole magnesiumEsomeprazole magnesium
    0186-0384Esomeprazole magnesiumEsomeprazole magnesium
    0186-4010NEXIUMEsomeprazole magnesium
    0186-4020NEXIUMEsomeprazole magnesium
    0186-4025NEXIUMEsomeprazole magnesium
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.