NDC 51079-007

Omeprazole

Omeprazole

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

Product ID51079-007_7e02f6ee-8d89-6aa2-e053-2991aa0a8d97
NDC51079-007
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2003-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA075876
Labeler NameMylan Institutional 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 51079-007-20

100 BLISTER PACK in 1 CARTON (51079-007-20) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (51079-007-01)
Marketing Start Date2003-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-007-01 [51079000701]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-09-01
Marketing End Date2019-09-30

NDC 51079-007-30 [51079000730]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-09-01
Marketing End Date2017-10-10

NDC 51079-007-20 [51079000720]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-09-01
Marketing End Date2019-09-30

NDC 51079-007-19 [51079000719]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-27
Marketing End Date2016-05-31

NDC 51079-007-17 [51079000717]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-09-01
Marketing End Date2017-10-10

NDC 51079-007-56 [51079000756]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-12-07
Marketing End Date2016-05-31

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:8809c12d-06de-4ccb-95d3-5108d2a955fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198051
  • Pharmacological Class

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

    Medicade Reported Pricing

    51079007820 HYDROXYZINE PAM 50 MG CAP

    Pricing Unit: EA | Drug Type:

    51079007801 HYDROXYZINE PAM 50 MG CAP

    Pricing Unit: EA | Drug Type:

    51079007720 HYDROXYZINE PAM 25 MG CAP

    Pricing Unit: EA | Drug Type:

    51079007701 HYDROXYZINE PAM 25 MG CAP

    Pricing Unit: EA | Drug Type:

    51079007620 HYDRALAZINE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007601 HYDRALAZINE 50 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007520 HYDRALAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007519 HYDRALAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007517 HYDRALAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007501 HYDRALAZINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007420 HYDRALAZINE 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007401 HYDRALAZINE 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007356 FUROSEMIDE 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007330 FUROSEMIDE 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007320 FUROSEMIDE 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007319 FUROSEMIDE 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007317 FUROSEMIDE 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007301 FUROSEMIDE 40 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007256 FUROSEMIDE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007230 FUROSEMIDE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007220 FUROSEMIDE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007219 FUROSEMIDE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007217 FUROSEMIDE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079007201 FUROSEMIDE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079000756 OMEPRAZOLE DR 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    51079000730 OMEPRAZOLE DR 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    51079000720 OMEPRAZOLE DR 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    51079000719 OMEPRAZOLE DR 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    51079000717 OMEPRAZOLE DR 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    51079000701 OMEPRAZOLE DR 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    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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