NDC 63304-445

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 Ranbaxy Laboratories Inc.. The primary component is Omeprazole.

Product ID63304-445_b43f6b44-9de3-4efb-a467-487aee28f6a0
NDC63304-445
Product TypeHuman Prescription Drug
Proprietary NameOmeprazole Delayed-Release
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-07-25
Marketing CategoryNDA / NDA
Application NumberNDA019810
Labeler NameRanbaxy Laboratories Inc.
Substance NameOMEPRAZOLE
Active Ingredient Strength40 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 63304-445-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-445-30)
Marketing Start Date2008-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63304-445-10 [63304044510]

Omeprazole Delayed-Release CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA019810
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-25
Inactivation Date2019-10-21

NDC 63304-445-30 [63304044530]

Omeprazole Delayed-Release CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA019810
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-25
Inactivation Date2019-10-21

NDC 63304-445-01 [63304044501]

Omeprazole Delayed-Release CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA019810
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-25
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE40 mg/1

OpenFDA Data

SPL SET ID:b43f6b44-9de3-4efb-a467-487aee28f6a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200329

    • 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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