NDC 59651-003

Omeprazole

Omeprazole

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

Product ID59651-003_0503ef43-97c1-490d-a470-a0cc39858f18
NDC59651-003
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-08-19
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA203270
Labeler NameAurobindo Pharma Limited
Substance NameOMEPRAZOLE
Active Ingredient Strength40 mg/1
Pharm ClassesCytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59651-003-01

100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-003-01)
Marketing Start Date2015-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59651-003-05 [59651000305]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-19

NDC 59651-003-10 [59651000310]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-19

NDC 59651-003-03 [59651000303]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-19

NDC 59651-003-99 [59651000399]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-03

NDC 59651-003-30 [59651000330]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-19

NDC 59651-003-90 [59651000390]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-19

NDC 59651-003-01 [59651000301]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-19

NDC 59651-003-78 [59651000378]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203270
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-08-19

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE40 mg/1

Medicade Reported Pricing

59651003247 IBUPROFEN 100 MG/5 ML SUSP

Pricing Unit: ML | Drug Type:

59651003212 IBUPROFEN 100 MG/5 ML SUSP

Pricing Unit: ML | Drug Type:

59651000305 OMEPRAZOLE DR 40 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

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