NDC 11383-257

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 Weeks & Leo Co., Inc.. The primary component is Omeprazole.

Product ID11383-257_5b04f51e-2b48-492b-84b1-22e988d46720
NDC11383-257
Product TypeHuman Otc Drug
Proprietary NameOmeprazole Delayed Release
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2011-07-12
Marketing CategoryNDA / NDA
Application NumberNDA022032
Labeler NameWeeks & Leo Co., Inc.
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 11383-257-16

1 BLISTER PACK in 1 CARTON (11383-257-16) > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2011-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11383-257-43 [11383025743]

Omeprazole Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-21
Inactivation Date2020-01-31

NDC 11383-257-61 [11383025761]

Omeprazole Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-07-12
Inactivation Date2020-01-31

NDC 11383-257-16 [11383025716]

Omeprazole Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA022032
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-07-12
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:bb7e658c-dab5-43b3-b5c2-578948164e63
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 402014
    • UPC Code
  • 0732363120407

    • Medicade Reported Pricing

    11383025761 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    11383025743 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    11383025716 OMEPRAZOLE DR 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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