NDC 51655-500

Pantoprazole Sodium Delayed Release

Pantoprazole Sodium Delayed Release

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

Product ID51655-500_abee16aa-a278-4e4e-bbce-3b2f0599ba2f
NDC51655-500
Product TypeHuman Prescription Drug
Proprietary NamePantoprazole Sodium Delayed Release
Generic NamePantoprazole Sodium Delayed Release
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-03-21
Marketing CategoryANDA / ANDA
Application NumberANDA090970
Labeler NameNorthwind Pharmaceuticals
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 51655-500-52

30 TABLET, DELAYED RELEASE in 1 BOTTLE, DISPENSING (51655-500-52)
Marketing Start Date2014-03-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51655-500-52 [51655050052]

Pantoprazole Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:bf31d3db-ed75-4513-a3a9-a163b5a5dceb
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 Delayed Release" or generic name "Pantoprazole Sodium Delayed Release"

    NDCBrand NameGeneric Name
    51655-500Pantoprazole Sodium Delayed ReleasePantoprazole Sodium Delayed Release
    58517-420PANTOPRAZOLE SODIUM Delayed ReleasePANTOPRAZOLE SODIUM Delayed Release
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.