NDC 45865-342

Omeprazole

Omeprazole

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

Product ID45865-342_4c9c1111-c13e-42fc-9c1d-5f9c54c86515
NDC45865-342
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA075576
Labeler NameMedsource Pharmaceuticals
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 45865-342-90

90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-342-90)
Marketing Start Date2008-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-342-60 [45865034260]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-12-17
Inactivation Date2019-11-13

NDC 45865-342-49 [45865034249]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-12-17
Inactivation Date2019-11-13

NDC 45865-342-90 [45865034290]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-12-17
Inactivation Date2019-11-13

NDC 45865-342-42 [45865034242]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-12-17
Inactivation Date2019-11-13

NDC 45865-342-15 [45865034215]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-12-17
Inactivation Date2019-11-13

NDC 45865-342-30 [45865034230]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-12-17
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:2f381ecb-1e71-4f2f-acf0-d4918e0f3a1c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198051

    • Pharmacological Class

    • 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.