protonix i.v.

Generic: pantoprazole sodium

Labeler: wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name protonix i.v.
Generic Name pantoprazole sodium
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pantoprazole sodium 40 mg/10mL

Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0008-4001
Product ID 0008-4001_d36cd2fb-517f-44e5-8438-53e563775f86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020988
Listing Expiration 2026-12-31
Marketing Start 2013-05-01

Pharmacologic Class

Classes
proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00084001
Hyphenated Format 0008-4001

Supplemental Identifiers

RxCUI
283669 885257
UNII
6871619Q5X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name protonix i.v. (source: ndc)
Generic Name pantoprazole sodium (source: ndc)
Application Number NDA020988 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/10mL
source: ndc
Packaging
  • 10 CARTON in 1 PACKAGE (0008-4001-10) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL
  • 25 CARTON in 1 PACKAGE (0008-4001-25) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL
source: ndc

Packages (2)

0008-4001-10 10 CARTON in 1 PACKAGE (0008-4001-10) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL 0008-4001-25 25 CARTON in 1 PACKAGE (0008-4001-25) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL

Ingredients (1)

pantoprazole sodium (40 mg/10mL)

Linked Drug Pages (1)

Protonix I.V. ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d36cd2fb-517f-44e5-8438-53e563775f86", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["283669", "885257"], "spl_set_id": ["f39b3e7d-39d2-4c8a-9974-4ab885241880"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 PACKAGE (0008-4001-10)  / 1 VIAL in 1 CARTON (0008-4001-01)  / 10 mL in 1 VIAL", "package_ndc": "0008-4001-10", "marketing_start_date": "20130501"}, {"sample": false, "description": "25 CARTON in 1 PACKAGE (0008-4001-25)  / 1 VIAL in 1 CARTON (0008-4001-01)  / 10 mL in 1 VIAL", "package_ndc": "0008-4001-25", "marketing_start_date": "20130501"}], "brand_name": "Protonix I.V.", "product_id": "0008-4001_d36cd2fb-517f-44e5-8438-53e563775f86", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0008-4001", "generic_name": "PANTOPRAZOLE SODIUM", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Protonix", "brand_name_suffix": "I.V.", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/10mL"}], "application_number": "NDA020988", "marketing_category": "NDA", "marketing_start_date": "20130501", "listing_expiration_date": "20261231"}