NDC 76420-055

Omeprazole

Omeprazole

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

Product ID76420-055_9c41bb55-3b26-7066-e053-2995a90a2139
NDC76420-055
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA091672
Labeler NameAsclemed USA, 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 76420-055-03

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-055-03)
Marketing Start Date2020-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76420-055-06 [76420005506]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 76420-055-03 [76420005503]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 76420-055-10 [76420005510]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

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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