NDC 35573-428

Pantoprazole Sodium

Pantoprazole Sodium

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

Product ID35573-428_23e35175-2c1c-45dc-beb6-6a8f9225dae0
NDC35573-428
Product TypeHuman Prescription Drug
Proprietary NamePantoprazole Sodium
Generic NamePantoprazole Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-04-20
Marketing CategoryANDA / ANDA
Application NumberANDA202038
Labeler NameBurel Pharmaceuticals, LLC
Substance NamePANTOPRAZOLE SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 35573-428-80

10 BLISTER PACK in 1 CARTON (35573-428-80) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Marketing Start Date2020-04-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35573-428-80 [35573042880]

Pantoprazole Sodium TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202038
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-20

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:3cc5197e-6b39-4415-b963-d4bbeecd7953
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.