NDC 68788-6881

Omeprazole

Omeprazole

Omeprazole is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Omeprazole.

Product ID68788-6881_3a795fac-05f5-4dbc-b61d-15921fe0488d
NDC68788-6881
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-01-20
Marketing CategoryANDA / ANDA
Application NumberANDA091672
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68788-6881-1

100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6881-1)
Marketing Start Date2017-01-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6881-8 [68788688108]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-20

NDC 68788-6881-9 [68788688109]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-20

NDC 68788-6881-2 [68788688102]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-20

NDC 68788-6881-6 [68788688106]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-20

NDC 68788-6881-1 [68788688101]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-20

NDC 68788-6881-3 [68788688103]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-01-20

NDC 68788-6881-4 [68788688104]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-20

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:aa8fc2ea-3942-453b-bc19-1e4b14ba6926
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198051
  • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.