NDC 58517-420

PANTOPRAZOLE SODIUM Delayed Release

Pantoprazole Sodium

PANTOPRAZOLE SODIUM Delayed Release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by New Horizon Rx Group, Llc. The primary component is Pantoprazole Sodium.

Product ID58517-420_3488e3d7-1285-4002-b351-15f59623a2eb
NDC58517-420
Product TypeHuman Prescription Drug
Proprietary NamePANTOPRAZOLE SODIUM Delayed Release
Generic NamePantoprazole Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-08-25
Marketing CategoryANDA / ANDA
Application NumberANDA077058
Labeler NameNew Horizon Rx Group, LLC
Substance NamePANTOPRAZOLE SODIUM
Active Ingredient Strength40 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58517-420-30

30 TABLET in 1 BOTTLE (58517-420-30)
Marketing Start Date2013-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58517-420-30 [58517042030]

PANTOPRAZOLE SODIUM Delayed Release TABLET
Marketing CategoryANDA
Application NumberANDA077058
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-25
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

OpenFDA Data

SPL SET ID:1e4edc4d-fa80-4afc-9864-59009764601f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314200
    • UPC Code
  • 0358517420300

    • Pharmacological Class

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

    Medicade Reported Pricing

    58517042030 PANTOPRAZOLE SOD DR 40 MG TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "PANTOPRAZOLE SODIUM Delayed Release" or generic name "Pantoprazole Sodium"

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