NDC 21695-108

Protonix

Pantoprazoel Sodium

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

• Product ID: 21695-108_cfeacb5c-8b1b-48f6-9acf-00044a8179b4
• NDC: 21695-108
• Product Type: Human Prescription Drug
• Proprietary Name: Protonix
• Generic Name: Pantoprazoel Sodium
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2001-08-28
• Marketing Category: NDA / NDA
• Application Number: NDA020987
• Labeler Name: Rebel Distributors Corp
• 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 21695-108-15

15 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-108-15)

• Marketing Start Date: 2001-08-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-108-15 [21695010815]

Protonix TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA020987
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-08-28
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
PANTOPRAZOLE SODIUM	40 mg/1

OpenFDA Data

• SPL SET ID: cfeacb5c-8b1b-48f6-9acf-00044a8179b4
• Manufacturer:
  • Rebel Distributors Corp
• 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" or generic name "Pantoprazoel Sodium"

NDC	Brand Name	Generic Name
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
21695-108	Protonix	pantoprazoel sodium
55154-4225	Protonix	pantoprazole sodium
55154-4232	Protonix	pantoprazole sodium
55154-4234	Protonix	pantoprazole sodium
55154-4236	Protonix	PANTOPRAZOLE SODIUM
80425-0085	Protonix	Protonix