NDC 70518-0537

omeprazole

Omeprazole

omeprazole is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Omeprazole.

Product ID70518-0537_4f99e001-5e59-5f6d-e054-00144ff8d46c
NDC70518-0537
Product TypeHuman Otc Drug
Proprietary Nameomeprazole
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-05-15
Marketing CategoryNDA / NDA
Application NumberNDA022032
Labeler NameREMEDYREPACK INC.
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0537-0

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0537-0)
Marketing Start Date2017-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0537-0 [70518053700]

omeprazole TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-15

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:1bd258fe-9c2f-4b0f-99dc-84474c298cad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402014
  • NDC Crossover Matching brand name "omeprazole" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    0093-5294OmeprazoleOmeprazole
    0363-0007omeprazoleOmeprazole
    0363-0915omeprazoleOmeprazole
    0363-1607OmeprazoleOmeprazole
    0363-1819omeprazoleomeprazole
    0363-9980OmeprazoleOMEPRAZOLE MAGNESIUM
    0378-5211Omeprazoleomeprazole
    0378-5222Omeprazoleomeprazole
    0378-6150Omeprazoleomeprazole
    0615-1359OmeprazoleOmeprazole
    0615-2302OmeprazoleOmeprazole
    0615-2305OmeprazoleOmeprazole
    0615-7933OmeprazoleOmeprazole
    0615-8079OmeprazoleOmeprazole
    0615-8320OmeprazoleOmeprazole
    0615-8406OmeprazoleOmeprazole
    0781-2234OmeprazoleOmeprazole
    68016-759OmeprazoleOmeprazole
    68071-1522OmeprazoleOmeprazole
    68071-2180OmeprazoleOmeprazole
    68071-1948OmeprazoleOmeprazole
    68071-3285OmeprazoleOmeprazole
    68071-3007OmeprazoleOmeprazole
    68071-2199OmeprazoleOmeprazole
    68071-4051OmeprazoleOmeprazole
    68071-3368OmeprazoleOmeprazole
    68071-4140OmeprazoleOmeprazole
    68071-4146OmeprazoleOmeprazole
    68071-4024OmeprazoleOmeprazole
    68071-4025OmeprazoleOmeprazole
    68084-466OmeprazoleOmeprazole
    68084-128OmeprazoleOmeprazole
    68151-3088OmeprazoleOmeprazole
    68382-411OmeprazoleOmeprazole
    68382-412OmeprazoleOmeprazole
    68382-500OmeprazoleOmeprazole
    68462-395OmeprazoleOmeprazole
    68462-396OmeprazoleOmeprazole
    68462-397OmeprazoleOmeprazole
    68788-6881OmeprazoleOmeprazole
    68788-1554OmeprazoleOmeprazole
    68788-9748OmeprazoleOmeprazole
    68788-6995OmeprazoleOmeprazole
    68788-9955OmeprazoleOmeprazole
    69181-158OmeprazoleOmeprazole
    69189-0147OmeprazoleOmeprazole
    69677-180OmeprazoleOmeprazole
    69618-047OmeprazoleOmeprazole
    69842-791OmeprazoleOmeprazole
    70518-0056OmeprazoleOmeprazole

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