NDC 43353-569

Pantoprazole Sodium

Pantoprazole

Pantoprazole Sodium 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 ID43353-569_3b96d2e8-c6df-487e-a159-b094dba435cf
NDC43353-569
Product TypeHuman Prescription Drug
Proprietary NamePantoprazole Sodium
Generic NamePantoprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA205119
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 43353-569-80

180 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-569-80)
Marketing Start Date2017-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-569-53 [43353056953]

Pantoprazole Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-25
Inactivation Date2020-01-31

NDC 43353-569-80 [43353056980]

Pantoprazole Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-25
Inactivation Date2020-01-31

NDC 43353-569-30 [43353056930]

Pantoprazole Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA205119
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:07d68e39-155f-4816-989c-4df00b5cca4b
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" or generic name "Pantoprazole"

    NDCBrand NameGeneric Name
    0093-0011Pantoprazole SodiumPantoprazole Sodium
    0093-0012Pantoprazole SodiumPantoprazole Sodium
    0143-9284Pantoprazole SodiumPantoprazole Sodium
    68071-1963Pantoprazole SodiumPantoprazole Sodium
    68071-3038PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM
    68071-1571Pantoprazole SodiumPantoprazole Sodium
    68071-2082Pantoprazole SodiumPantoprazole Sodium
    68071-2195Pantoprazole SodiumPantoprazole Sodium
    68071-3140Pantoprazole SodiumPantoprazole Sodium
    68071-3373Pantoprazole SodiumPantoprazole Sodium
    68071-3334Pantoprazole SodiumPantoprazole Sodium
    68071-4211Pantoprazole SodiumPantoprazole Sodium
    68071-4483Pantoprazole SodiumPantoprazole Sodium
    68071-4646Pantoprazole SodiumPantoprazole Sodium
    68071-4347Pantoprazole SodiumPantoprazole Sodium
    68084-643Pantoprazole SodiumPantoprazole Sodium
    68084-813Pantoprazole SodiumPantoprazole Sodium
    68645-491Pantoprazole SodiumPantoprazole Sodium
    68645-492Pantoprazole SodiumPantoprazole Sodium
    68788-6326Pantoprazole SodiumPantoprazole Sodium
    68788-9263Pantoprazole SodiumPantoprazole Sodium
    68788-9557PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM
    68788-9660Pantoprazole SodiumPantoprazole Sodium
    68788-9254Pantoprazole SodiumPantoprazole Sodium
    68788-9510Pantoprazole SodiumPantoprazole Sodium
    68788-9419Pantoprazole SodiumPantoprazole Sodium
    70332-301Pantoprazole SodiumPantoprazole Sodium
    70332-300PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM
    70518-0226Pantoprazole SodiumPantoprazole Sodium
    70518-0012Pantoprazole SodiumPantoprazole Sodium
    70518-0395Pantoprazole SodiumPantoprazole Sodium
    70518-0286Pantoprazole SodiumPantoprazole Sodium
    70518-0860Pantoprazole SodiumPantoprazole Sodium
    70518-0962Pantoprazole SodiumPantoprazole Sodium
    70518-1298Pantoprazole SodiumPantoprazole Sodium
    70518-1264Pantoprazole SodiumPantoprazole Sodium
    70518-1788Pantoprazole SodiumPantoprazole Sodium
    70934-203Pantoprazole SodiumPantoprazole Sodium
    70934-145Pantoprazole SodiumPantoprazole Sodium
    71335-0310Pantoprazole SodiumPantoprazole Sodium
    71335-0476Pantoprazole SodiumPantoprazole Sodium
    71335-0715Pantoprazole SodiumPantoprazole Sodium
    71335-0291Pantoprazole SodiumPantoprazole Sodium
    71610-003Pantoprazole SodiumPantoprazole Sodium
    71335-0212Pantoprazole SodiumPantoprazole Sodium
    71610-103Pantoprazole SodiumPantoprazole Sodium
    71610-227Pantoprazole SodiumPantoprazole Sodium
    71610-099Pantoprazole SodiumPantoprazole Sodium
    0615-7629Pantoprazole SodiumPantoprazole Sodium
    0615-7916Pantoprazole SodiumPantoprazole Sodium

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