NDC 53808-1081

Pantoprazole

Pantoprazole

Pantoprazole is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Pantoprazole Sodium.

Product ID53808-1081_5381ed3f-3485-4c31-aac4-34a168296844
NDC53808-1081
Product TypeHuman Prescription Drug
Proprietary NamePantoprazole
Generic NamePantoprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA077619
Labeler NameState of Florida DOH Central Pharmacy
Substance NamePANTOPRAZOLE SODIUM
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53808-1081-1

30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (53808-1081-1)
Marketing Start Date2014-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-1081-1 [53808108101]

Pantoprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA077619
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM20 mg/1

OpenFDA Data

SPL SET ID:df37e937-6062-47bd-99ea-6ece768daa92
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314200
  • 251872
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Pantoprazole" or generic name "Pantoprazole"

    NDCBrand NameGeneric Name
    53808-1007PantoprazolePantoprazole
    53808-1081PantoprazolePantoprazole
    55111-332PantoprazolePantoprazole
    55111-333PantoprazolePantoprazole
    60760-574PantoprazolePantoprazole
    31722-712PANTOPRAZOLE SODIUMPANTOPRAZOLE
    31722-713PANTOPRAZOLE SODIUMPANTOPRAZOLE
    42708-104PANTOPRAZOLE SODIUMPANTOPRAZOLE
    43353-569Pantoprazole SodiumPantoprazole
    45865-130PANTOPRAZOLE SODIUMPANTOPRAZOLE
    45865-676Pantoprazole SodiumPantoprazole
    50090-5793PANTOPRAZOLE SODIUMPANTOPRAZOLE
    50090-5794PANTOPRAZOLE SODIUMPANTOPRAZOLE
    50436-0712PANTOPRAZOLE SODIUMPANTOPRAZOLE
    55700-790PANTOPRAZOLE SODIUMPANTOPRAZOLE
    55700-850PANTOPRAZOLE SODIUMPANTOPRAZOLE
    60760-679PANTOPRAZOLE SODIUMPANTOPRAZOLE
    60760-712PANTOPRAZOLE SODIUMPANTOPRAZOLE
    63187-654PANTOPRAZOLE SODIUMPANTOPRAZOLE
    63187-831PANTOPRAZOLE SODIUMPANTOPRAZOLE
    63187-837Pantoprazole SodiumPantoprazole

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