NDC 70934-433

OMEPRAZOLE

Omeprazole

OMEPRAZOLE is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. The primary component is Omeprazole.

Product ID70934-433_960fd285-b69f-e9ac-e053-2995a90afcc2
NDC70934-433
Product TypeHuman Prescription Drug
Proprietary NameOMEPRAZOLE
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2019-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA203481
Labeler NameDenton Pharma, Inc. DBA Northwind Pharmaceuticals
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 Through2020-12-31

Packaging

NDC 70934-433-14

14 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70934-433-14)
Marketing Start Date2019-08-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70934-433-30 [70934043330]

OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203481
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-06

NDC 70934-433-60 [70934043360]

OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203481
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-26

NDC 70934-433-90 [70934043390]

OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203481
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-13

NDC 70934-433-14 [70934043314]

OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203481
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-28

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

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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