NDC 68016-759

Omeprazole

Omeprazole

Omeprazole is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Chain Drug Consortium, Llc. The primary component is Omeprazole Magnesium.

Product ID68016-759_7dcc6136-3d48-6a68-e053-2a91aa0af765
NDC68016-759
Product TypeHuman Otc Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA078878
Labeler NameChain Drug Consortium, LLC
Substance NameOMEPRAZOLE MAGNESIUM
Active Ingredient Strength21 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68016-759-14

1 BOTTLE in 1 CARTON (68016-759-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2016-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-759-14 [68016075914]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078878
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-01

NDC 68016-759-28 [68016075928]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078878
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-01

NDC 68016-759-42 [68016075942]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA078878
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-01

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE MAGNESIUM20.6 mg/1

OpenFDA Data

SPL SET ID:616d8c9b-5d37-9fb3-e053-2a91aa0ac9a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198051

    • 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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