NDC 43353-338

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 Aphena Pharma Solutions - Tennessee, Llc. The primary component is Pantoprazole Sodium.

Product ID43353-338_d210a49a-4415-4bb1-b333-8027e459711b
NDC43353-338
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 NameAphena Pharma Solutions - Tennessee, LLC
Substance NamePANTOPRAZOLE SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-338-88

900 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-338-88)
Marketing Start Date2008-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-338-53 [43353033853]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Inactivation Date2020-01-31

NDC 43353-338-60 [43353033860]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-19
Inactivation Date2020-01-31

NDC 43353-338-88 [43353033888]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Inactivation Date2020-01-31

NDC 43353-338-30 [43353033830]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Inactivation Date2020-01-31

NDC 43353-338-09 [43353033809]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-19
Inactivation Date2020-01-31

NDC 43353-338-79 [43353033879]

Pantoprazole Sodium Delayed-Release TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA020987
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:03974abc-ad03-44da-b7b6-d8e6c4a06105
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314200

    • 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
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