NDC 53808-0745

Omeprazole Delayed-Release

Omeprazole

Omeprazole Delayed-Release is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Doh Central Pharmacy. The primary component is Omeprazole.

Product ID53808-0745_4c58bcb1-6e1f-44cd-a542-305c8b9898ce
NDC53808-0745
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole Delayed-Release
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA076048
Labeler NameDOH CENTRAL PHARMACY
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 Through2019-12-31

Packaging

NDC 53808-0745-1

30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (53808-0745-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0745-1 [53808074501]

Omeprazole Delayed-Release CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA076048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

OpenFDA Data

SPL SET ID:83a0bb34-405b-4aea-9557-4f8b8fd811d7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198051
  • UPC Code
  • 0360505006526
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Omeprazole Delayed-Release" or generic name "Omeprazole"

    NDCBrand NameGeneric Name
    53808-0745Omeprazole Delayed-ReleaseOmeprazole Delayed-Release
    63304-445Omeprazole Delayed-ReleaseOmeprazole Delayed-Release
    0363-1008Acid ReducerOmeprazole
    0536-1322Acid ReducerOmeprazole
    0113-7401Basic Care OmeprazoleOmeprazole
    0113-7520basic care omeprazoleomeprazole
    0113-7915Basic Care OmeprazoleOmeprazole
    0113-0520good sense omeprazoleomeprazole
    0113-0915Good Sense OmeprazoleOmeprazole
    0113-1723Good Sense OmeprazoleOmeprazole
    0113-1803good sense omeprazole delayed releaseomeprazole
    0093-5294OmeprazoleOmeprazole
    0363-0007omeprazoleOmeprazole
    0363-0915omeprazoleOmeprazole
    0363-1607OmeprazoleOmeprazole
    0363-1819omeprazoleomeprazole
    0378-5211Omeprazoleomeprazole
    0378-5222Omeprazoleomeprazole
    0378-6150Omeprazoleomeprazole
    0615-1359OmeprazoleOmeprazole
    0615-2302OmeprazoleOmeprazole
    0615-2305OmeprazoleOmeprazole
    0615-7933OmeprazoleOmeprazole
    0615-8079OmeprazoleOmeprazole
    0615-8320OmeprazoleOmeprazole
    0615-8406OmeprazoleOmeprazole
    0781-2234OmeprazoleOmeprazole

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