NDC 61919-176

OMEPRAZOLE DR

Omeprazole Dr

OMEPRAZOLE DR is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Omeprazole.

Product ID61919-176_4144b16e-5027-009d-e054-00144ff88e88
NDC61919-176
Product TypeHuman Prescription Drug
Proprietary NameOMEPRAZOLE DR
Generic NameOmeprazole Dr
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA076048
Labeler NameDirect Rx
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-176-14

14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-176-14)
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-176-90 [61919017690]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA076048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Marketing End Date2020-01-30

NDC 61919-176-72 [61919017672]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA076048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Marketing End Date2020-01-30

NDC 61919-176-15 [61919017615]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA076048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

NDC 61919-176-60 [61919017660]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA076048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Marketing End Date2020-01-30

NDC 61919-176-30 [61919017630]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA076048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01
Marketing End Date2020-01-30

NDC 61919-176-14 [61919017614]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA076048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:c6bc8fb7-2862-464a-b7c9-e409034f072a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200329
  • 198051
  • Pharmacological Class

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

    NDC Crossover Matching brand name "OMEPRAZOLE DR" or generic name "Omeprazole Dr"

    NDCBrand NameGeneric Name
    61919-176OMEPRAZOLE DROMEPRAZOLE DR
    61919-773OMEPRAZOLE DROMEPRAZOLE DR
    61919-807OMEPRAZOLE DROMEPRAZOLE DR
    51655-022OMEPRAZOLEOMEPRAZOLE DR

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