NDC 53002-1104

Omeprazole

Omeprazole

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

Product ID53002-1104_81399540-6952-4c7e-970a-cea00f4e4434
NDC53002-1104
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2009-01-21
Marketing CategoryANDA / ANDA
Application NumberANDA075576
Labeler NameRPK 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 Through2019-12-31

Packaging

NDC 53002-1104-0

100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-1104-0)
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1104-3 [53002110403]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1104-6 [53002110406]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1104-9 [53002110409]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1104-0 [53002110400]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075576
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:4438a8ee-dfc3-42ae-8057-f5992606891f
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
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