pantoprazole sodium

Generic: pantoprazole sodium

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pantoprazole sodium 40 mg/10mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-600
Product ID 71288-600_941d4274-57b1-4c13-a7e6-cbebfca66343
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215860
Listing Expiration 2026-12-31
Marketing Start 2022-08-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288600
Hyphenated Format 71288-600

Supplemental Identifiers

RxCUI
283669
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 ANDA215860 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/10mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-600-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-600-10)
source: ndc

Packages (1)

Ingredients (1)

pantoprazole sodium (40 mg/10mL)

Linked Drug Pages (2)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "941d4274-57b1-4c13-a7e6-cbebfca66343", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["283669"], "spl_set_id": ["c18aff31-f91e-4b6a-9713-52c9094c6082"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-600-11)  / 10 mL in 1 VIAL, SINGLE-DOSE (71288-600-10)", "package_ndc": "71288-600-11", "marketing_start_date": "20220829"}], "brand_name": "Pantoprazole Sodium", "product_id": "71288-600_941d4274-57b1-4c13-a7e6-cbebfca66343", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71288-600", "generic_name": "Pantoprazole Sodium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/10mL"}], "application_number": "ANDA215860", "marketing_category": "ANDA", "marketing_start_date": "20220829", "listing_expiration_date": "20261231"}