NDC 71610-280

Omeprazole

Omeprazole

Omeprazole is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Omeprazole.

Product ID71610-280_5cbc3e43-cf72-4e22-96f3-0de16d3894bf
NDC71610-280
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 NameAphena Pharma Solutions - Tennessee, LLC
Substance NameOMEPRAZOLE
Active Ingredient Strength40 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 71610-280-60

90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-280-60)
Marketing Start Date2019-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-280-60 [71610028060]

Omeprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-22

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE40 mg/1

Pharmacological Class

  • Proton Pump Inhibitor [EPC]
  • Proton Pump Inhibitors [MoA]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • 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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.