NDC 63187-005

Pantoprazole Sodium Delayed-Release

Pantoprazole Sodium

Pantoprazole Sodium Delayed-Release is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx. The primary component is Pantoprazole Sodium.

Product ID63187-005_940c4ba6-80f4-4c9c-831d-1d166ef9a3fe
NDC63187-005
Product TypeHuman Prescription Drug
Proprietary NamePantoprazole Sodium Delayed-Release
Generic NamePantoprazole Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2008-01-31
Marketing CategoryNDA / NDA
Application NumberNDA020987
Labeler NameProficient Rx
Substance NamePANTOPRAZOLE SODIUM
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63187-005-90

90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-005-90)
Marketing Start Date2008-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-005-90 [63187000590]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-01
Marketing End Date2015-05-01
Inactivation Date2019-11-27
Reactivation Date2019-12-04

NDC 63187-005-60 [63187000560]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-01
Marketing End Date2015-05-01
Inactivation Date2019-11-27
Reactivation Date2019-12-04

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM20 mg/1

OpenFDA Data

SPL SET ID:940c4ba6-80f4-4c9c-831d-1d166ef9a3fe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 251872

    • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]

    NDC Crossover Matching brand name "Pantoprazole Sodium Delayed-Release" or generic name "Pantoprazole Sodium"

    NDCBrand NameGeneric Name
    43353-338Pantoprazole Sodium Delayed-ReleasePantoprazole Sodium Delayed-Release
    63187-005Pantoprazole Sodium Delayed-ReleasePantoprazole Sodium Delayed-Release
    67046-535Pantoprazole Sodium Delayed-ReleasePantoprazole Sodium Delayed-Release
    0093-0011Pantoprazole SodiumPantoprazole Sodium
    0093-0012Pantoprazole SodiumPantoprazole Sodium
    0143-9284Pantoprazole SodiumPantoprazole Sodium
    0008-0841ProtonixPANTOPRAZOLE SODIUM
    0008-0843ProtonixPANTOPRAZOLE SODIUM
    0008-0844ProtonixPANTOPRAZOLE SODIUM
    0008-0923ProtonixPANTOPRAZOLE SODIUM
    0008-0941Protonixpantoprazole sodium
    0008-2001ProtonixPANTOPRAZOLE SODIUM
    0008-4001ProtonixPANTOPRAZOLE SODIUM
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.