NDC 70518-0012

Pantoprazole Sodium

Pantoprazole Sodium

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

Product ID70518-0012_81509637-54f9-1325-e053-2a91aa0ae45b
NDC70518-0012
Product TypeHuman Prescription Drug
Proprietary NamePantoprazole Sodium
Generic NamePantoprazole Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2016-11-22
Marketing CategoryANDA / ANDA
Application NumberANDA090074
Labeler NameREMEDYREPACK INC.
Substance NamePANTOPRAZOLE SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0012-1

90 TABLET, DELAYED RELEASE in 1 BOTTLE (70518-0012-1)
Marketing Start Date2016-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0012-0 [70518001200]

Pantoprazole Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090074
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-22
Marketing End Date2018-11-15

NDC 70518-0012-1 [70518001201]

Pantoprazole Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090074
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-29

NDC 70518-0012-2 [70518001202]

Pantoprazole Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090074
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-17
Marketing End Date2018-08-17

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:c7b8f2e7-e9d6-4b1d-b392-aaadbe1dbfe0
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 Sodium"

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.