NDC 36800-915

TopCare Omeprazole

Omeprazole

TopCare Omeprazole 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 ID36800-915_0d4bfaa9-04bd-49a3-a0e3-ef012dd4f995
NDC36800-915
Product TypeHuman Otc Drug
Proprietary NameTopCare Omeprazole
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-02-29
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 36800-915-01

1 BOTTLE in 1 CARTON (36800-915-01) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2010-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-915-30 [36800091530]

TopCare Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2008-02-29

NDC 36800-915-74 [36800091574]

TopCare Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2008-02-29

NDC 36800-915-55 [36800091555]

TopCare Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2008-02-29

NDC 36800-915-01 [36800091501]

TopCare Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2010-10-11

NDC 36800-915-03 [36800091503]

TopCare Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-12-28

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:4d98665d-38db-4c08-8406-cc0e45f7ab7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402014

    • Medicade Reported Pricing

    36800091574 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    36800091555 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    36800091530 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    36800091503 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    36800091501 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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