"36800-627-01" National Drug Code (NDC)

Topcare Esomeprazole Magnesium 1 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
(Topco Associates LLC)

NDC Code36800-627-01
Package Description1 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product NDC36800-627
Product Type NameHUMAN OTC DRUG
Proprietary NameTopcare Esomeprazole Magnesium
Non-Proprietary NameEsomeprazole Magnesium
Dosage FormCAPSULE, DELAYED RELEASE
UsageORAL
Start Marketing Date20200312
Marketing Category NameANDA
Application NumberANDA207193
ManufacturerTopco Associates LLC
Substance NameESOMEPRAZOLE MAGNESIUM DIHYDRATE
Strength20
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]

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