NDC 64861-303

Omeprazole Delayed Release

Omeprazole

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

Product ID64861-303_5b97f373-690c-4a84-b3f6-24353f50f771
NDC64861-303
Product TypeHuman Otc Drug
Proprietary NameOmeprazole Delayed Release
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-03-01
Marketing CategoryNDA / NDA
Application NumberNDA022032
Labeler NameDexcel Ltd.
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 64861-303-03

2 BLISTER PACK in 1 CARTON (64861-303-03) > 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2008-03-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:80e8ed4e-25af-4297-bd15-901e6120323d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402014

    • NDC Crossover Matching brand name "Omeprazole Delayed Release" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    11383-257Omeprazole Delayed ReleaseOmeprazole Delayed Release
    64861-303Omeprazole Delayed ReleaseOmeprazole 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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