NDC 36800-121

TopCare Omeprazole delayed release

Omeprazole

TopCare Omeprazole delayed release is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Omeprazole.

Product ID36800-121_8ca43c38-6c67-4af8-b7ba-ab2adbb65233
NDC36800-121
Product TypeHuman Otc Drug
Proprietary NameTopCare Omeprazole delayed release
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-02-02
Marketing CategoryNDA / NDA
Application NumberNDA022032
Labeler NameTopco Associates LLC
Substance NameOMEPRAZOLE
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 36800-121-01

1 BOTTLE in 1 CARTON (36800-121-01) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2016-02-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-121-01 [36800012101]

TopCare Omeprazole delayed release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-17

NDC 36800-121-03 [36800012103]

TopCare Omeprazole delayed release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-02

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:8ed57521-e69a-4563-9ce2-4f6d667f065d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402014

    • NDC Crossover Matching brand name "TopCare Omeprazole delayed release" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    36800-121TopCare Omeprazole delayed releaseTopCare Omeprazole delayed release
    0363-1008Acid ReducerOmeprazole
    0536-1322Acid ReducerOmeprazole
    0113-7401Basic Care OmeprazoleOmeprazole
    0113-7520basic care omeprazoleomeprazole
    0113-7915Basic Care OmeprazoleOmeprazole
    0113-0520good sense omeprazoleomeprazole
    0113-0915Good Sense OmeprazoleOmeprazole
    0113-1723Good Sense OmeprazoleOmeprazole
    0113-1803good sense omeprazole delayed releaseomeprazole
    0093-5294OmeprazoleOmeprazole
    0363-0007omeprazoleOmeprazole
    0363-0915omeprazoleOmeprazole
    0363-1607OmeprazoleOmeprazole
    0363-1819omeprazoleomeprazole
    0378-5211Omeprazoleomeprazole
    0378-5222Omeprazoleomeprazole
    0378-6150Omeprazoleomeprazole
    0615-1359OmeprazoleOmeprazole
    0615-2302OmeprazoleOmeprazole
    0615-2305OmeprazoleOmeprazole
    0615-7933OmeprazoleOmeprazole
    0615-8079OmeprazoleOmeprazole
    0615-8320OmeprazoleOmeprazole
    0615-8406OmeprazoleOmeprazole
    0781-2234OmeprazoleOmeprazole
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