NDC 0008-2001

Protonix I.V.

Pantoprazole Sodium

Protonix I.V. is a Intravenous Injection, Powder, For Solution 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: 0008-2001_1e8fa399-506d-4bcd-9097-dbf7850147bf
• NDC: 0008-2001
• Product Type: Human Prescription Drug
• Proprietary Name: Protonix I.V.
• Generic Name: Pantoprazole Sodium
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-03-17
• Marketing Category: NDA / NDA
• Application Number: NDA020988
• Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: PANTOPRAZOLE SODIUM
• Active Ingredient Strength: 40 mg/10mL
• Pharm Classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0008-2001-10

10 CARTON in 1 PACKAGE (0008-2001-10) > 1 VIAL in 1 CARTON (0008-2001-01) > 10 mL in 1 VIAL

• Marketing Start Date: 2014-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0008-2001-10 [00008200110]

Protonix I.V. INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020988
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-03-17

NDC 0008-2001-25 [00008200125]

Protonix I.V. INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020988
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-03-17

NDC 0008-2001-01 [00008200101]

Protonix I.V. INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020988
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-03-17

Drug Details

Active Ingredients

Ingredient	Strength
PANTOPRAZOLE SODIUM	40 mg/10mL

Pharmacological Class

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

NDC Crossover Matching brand name "Protonix I.V." or generic name "Pantoprazole Sodium"

NDC	Brand Name	Generic Name
55154-4225	Protonix I.V.	Protonix I.V.
55154-4234	Protonix I.V.	Protonix I.V.
55154-4236	Protonix I.V.	Protonix I.V.
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