NDC 36800-601

topcare omeprazole

Omeprazole

topcare omeprazole is a Oral Tablet, Orally Disintegrating, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Omeprazole.

Product ID36800-601_5b5a2c7c-c070-48f5-9bf5-902b42e15b9b
NDC36800-601
Product TypeHuman Otc Drug
Proprietary Nametopcare omeprazole
Generic NameOmeprazole
Dosage FormTablet, Orally Disintegrating, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-04-02
Marketing CategoryNDA / NDA
Application NumberNDA209400
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 36800-601-55

3 CARTON in 1 CARTON (36800-601-55) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-601-74 [36800060174]

topcare omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA209400
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-02

NDC 36800-601-55 [36800060155]

topcare omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA209400
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-02

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:436c5ea1-c5ee-481f-803d-439f65873b1c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2003656

    • NDC Crossover Matching brand name "topcare omeprazole" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    36800-915TopCare OmeprazoleTopCare Omeprazole
    36800-601topcare omeprazoletopcare omeprazole
    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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