NDC 70000-0381

Leader Omeprazole

Omeprazole

Leader Omeprazole is a Oral Tablet, Orally Disintegrating, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Cardinal Health 110, Llc. Dba Leader. The primary component is Omeprazole.

Product ID70000-0381_487374b4-a751-46cc-bc58-6e2dc8589846
NDC70000-0381
Product TypeHuman Otc Drug
Proprietary NameLeader Omeprazole
Generic NameOmeprazole
Dosage FormTablet, Orally Disintegrating, Delayed Release
Route of AdministrationORAL
Marketing Start Date2018-08-20
Marketing CategoryNDA / NDA
Application NumberNDA209400
Labeler NameCardinal Health 110, LLC. dba Leader
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70000-0381-1

14 BLISTER PACK in 1 CARTON (70000-0381-1) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0381-1 [70000038101]

Leader Omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA209400
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-08-20

NDC 70000-0381-2 [70000038102]

Leader Omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA209400
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-08-20

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2003656

    • NDC Crossover Matching brand name "Leader Omeprazole" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    70000-0356leader omeprazoleleader omeprazole
    70000-0381Leader OmeprazoleLeader Omeprazole
    37205-837leader omeprazoleleader 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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