pantoprazole sodium

Generic: pantoprazole sodium in 0.9% sodium chloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium in 0.9% sodium chloride
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pantoprazole sodium 40 mg/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-9644
Product ID 0338-9644_290e26a2-61f1-4840-9819-205212c7d365
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217512
Listing Expiration 2026-12-31
Marketing Start 2024-02-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03389644
Hyphenated Format 0338-9644

Supplemental Identifiers

RxCUI
2675781 2675784 2675786
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 pantoprazole sodium (source: ndc)
Generic Name pantoprazole sodium in 0.9% sodium chloride (source: ndc)
Application Number NDA217512 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/100mL
source: ndc
Packaging
  • 12 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01)
source: ndc

Packages (1)

0338-9644-12 12 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01)

Ingredients (1)

pantoprazole sodium (40 mg/100mL)

Linked Drug Pages (1)

PANTOPRAZOLE SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "290e26a2-61f1-4840-9819-205212c7d365", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["2675781", "2675784", "2675786"], "spl_set_id": ["a476e063-9450-4793-9a22-16b0a0a61cd0"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CARTON (0338-9644-12)  / 100 mL in 1 BAG (0338-9644-01)", "package_ndc": "0338-9644-12", "marketing_start_date": "20240214"}], "brand_name": "PANTOPRAZOLE SODIUM", "product_id": "0338-9644_290e26a2-61f1-4840-9819-205212c7d365", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0338-9644", "generic_name": "Pantoprazole Sodium in 0.9% Sodium Chloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANTOPRAZOLE SODIUM", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/100mL"}], "application_number": "NDA217512", "marketing_category": "NDA", "marketing_start_date": "20240214", "listing_expiration_date": "20261231"}