NDC 69189-0841

Protonix Delayed-Release

Pantoprazole Sodium

Protonix Delayed-Release is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Pantoprazole Sodium.

• Product ID: 69189-0841_9b04facd-97eb-4e60-8ded-f4c97251427b
• NDC: 69189-0841
• Product Type: Human Prescription Drug
• Proprietary Name: Protonix Delayed-Release
• Generic Name: Pantoprazole Sodium
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-21
• Marketing Category: NDA / NDA
• Application Number: NDA020987
• Labeler Name: Avera McKennan Hospital
• Substance Name: PANTOPRAZOLE SODIUM
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 69189-0841-1

1 TABLET, DELAYED RELEASE in 1 DOSE PACK (69189-0841-1)

• Marketing Start Date: 2015-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69189-0841-1 [69189084101]

Protonix Delayed-Release TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA020987
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-21
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PANTOPRAZOLE SODIUM	40 mg/1

OpenFDA Data

• SPL SET ID: efd8122a-021b-4e1d-a805-37e736738424
• Manufacturer:
  • Avera McKennan Hospital
• UNII:
  • 6871619Q5X
• RxNorm Concept Unique ID - RxCUI:
  • 284400
  • 314200

Pharmacological Class

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

NDC Crossover Matching brand name "Protonix Delayed-Release" or generic name "Pantoprazole Sodium"

NDC	Brand Name	Generic Name
69189-0841	Protonix Delayed-Release	Protonix Delayed-Release
55154-4232	Protonix Delayed-Release	Protonix Delayed-Release
0093-0011	Pantoprazole Sodium	Pantoprazole Sodium
0093-0012	Pantoprazole Sodium	Pantoprazole Sodium
0143-9284	Pantoprazole Sodium	Pantoprazole Sodium
0008-0841	Protonix	PANTOPRAZOLE SODIUM
0008-0843	Protonix	PANTOPRAZOLE SODIUM
0008-0844	Protonix	PANTOPRAZOLE SODIUM
0008-0923	Protonix	PANTOPRAZOLE SODIUM
0008-0941	Protonix	pantoprazole sodium
0008-2001	Protonix	PANTOPRAZOLE SODIUM
0008-4001	Protonix	PANTOPRAZOLE SODIUM