NDC 51655-501

Pantoprazole Sodium DR

Pantoprazole Sodium

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

Product ID51655-501_9fe62b0e-e0ec-4b5b-8431-d211b60a85c3
NDC51655-501
Product TypeHuman Prescription Drug
Proprietary NamePantoprazole Sodium DR
Generic NamePantoprazole Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-07-16
Marketing CategoryANDA / ANDA
Application NumberANDA077056
Labeler NameNorthwind Pharmaceuticals, LLC
Substance NamePANTOPRAZOLE SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 51655-501-52

30 TABLET, DELAYED RELEASE in 1 BOTTLE, DISPENSING (51655-501-52)
Marketing Start Date2014-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-501-52 [51655050152]

Pantoprazole Sodium DR TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA077056
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-07-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:25a1efd6-b6e1-4367-8f74-0f4b8087ae99
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 DR" or generic name "Pantoprazole Sodium"

    NDCBrand NameGeneric Name
    51655-501Pantoprazole Sodium DRPantoprazole Sodium DR
    61919-806PANTOPRAZOLE SODIUM DRPANTOPRAZOLE SODIUM DR
    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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