pantoprazole sodium

Generic: pantoprazole sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pantoprazole sodium 40 mg/10mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-385
Product ID 65219-385_452b14d4-4fbd-47b1-b4b1-f0b302e8f0d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216021
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219385
Hyphenated Format 65219-385

Supplemental Identifiers

RxCUI
283669
UPC
0365219385011
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 (source: ndc)
Application Number ANDA216021 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (65219-385-10) / 10 mL in 1 VIAL (65219-385-01)
source: ndc

Packages (1)

65219-385-10 10 VIAL in 1 CARTON (65219-385-10) / 10 mL in 1 VIAL (65219-385-01)

Ingredients (1)

pantoprazole sodium (40 mg/10mL)

Linked Drug Pages (1)

Pantoprazole Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "452b14d4-4fbd-47b1-b4b1-f0b302e8f0d9", "openfda": {"upc": ["0365219385011"], "unii": ["6871619Q5X"], "rxcui": ["283669"], "spl_set_id": ["340b57c2-bcf8-4f46-b522-886daaf80351"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (65219-385-10)  / 10 mL in 1 VIAL (65219-385-01)", "package_ndc": "65219-385-10", "marketing_start_date": "20250131"}], "brand_name": "Pantoprazole Sodium", "product_id": "65219-385_452b14d4-4fbd-47b1-b4b1-f0b302e8f0d9", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "65219-385", "generic_name": "Pantoprazole Sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/10mL"}], "application_number": "ANDA216021", "marketing_category": "ANDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}