NDC 0008-0844

Protonix Delayed-Release

Pantoprazole Sodium

Protonix Delayed-Release is a Oral Granule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Pantoprazole Sodium.

• Product ID: 0008-0844_29251289-9ecc-4c20-9669-3455d904171a
• NDC: 0008-0844
• Product Type: Human Prescription Drug
• Proprietary Name: Protonix Delayed-Release
• Generic Name: Pantoprazole Sodium
• Dosage Form: Granule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2008-02-29
• Marketing Category: NDA / NDA
• Application Number: NDA022020
• Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: PANTOPRAZOLE SODIUM
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0008-0844-02

30 PACKET in 1 CARTON (0008-0844-02) > 1 GRANULE, DELAYED RELEASE in 1 PACKET (0008-0844-01)

• Marketing Start Date: 2008-02-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0008-0844-01 [00008084401]

Protonix Delayed-Release GRANULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA022020
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-02-29

NDC 0008-0844-02 [00008084402]

Protonix Delayed-Release GRANULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA022020
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-02-29

Drug Details

Active Ingredients

Ingredient	Strength
PANTOPRAZOLE SODIUM	40 mg/1

OpenFDA Data

• SPL SET ID: 08098cb2-c048-4640-f387-6beec4a38936
• Manufacturer:
  • Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• UNII:
  • 6871619Q5X
• RxNorm Concept Unique ID - RxCUI:
  • 314200
  • 251872
  • 352125
  • 763306
  • 284400
  • 763308
• UPC Code:
  • 0300080843819
  • 0300080841815

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