pantoprazole sodium i.v.

Generic: pantoprazole sodium

Labeler: piramal critical care
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium i.v.
Generic Name pantoprazole sodium
Labeler piramal critical care
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pantoprazole sodium 40 mg/10mL

Manufacturer
Piramal Critical Care

Identifiers & Regulatory

Product NDC 66794-258
Product ID 66794-258_390349ed-4093-e0b3-e063-6294a90a474e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214680
Listing Expiration 2026-12-31
Marketing Start 2023-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66794258
Hyphenated Format 66794-258

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 i.v. (source: ndc)
Generic Name pantoprazole sodium (source: ndc)
Application Number ANDA214680 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (66794-258-41) / 10 mL in 1 VIAL
source: ndc

Packages (1)

66794-258-41 1 VIAL in 1 CARTON (66794-258-41) / 10 mL in 1 VIAL

Ingredients (1)

pantoprazole sodium (40 mg/10mL)

Linked Drug Pages (1)

PANTOPRAZOLE SODIUM I.V. ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "390349ed-4093-e0b3-e063-6294a90a474e", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["283669"], "spl_set_id": ["0696b10c-972b-9dcf-e063-6294a90a1034"], "manufacturer_name": ["Piramal Critical Care"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (66794-258-41)  / 10 mL in 1 VIAL", "package_ndc": "66794-258-41", "marketing_start_date": "20231010"}], "brand_name": "PANTOPRAZOLE SODIUM I.V.", "product_id": "66794-258_390349ed-4093-e0b3-e063-6294a90a474e", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "66794-258", "generic_name": "PANTOPRAZOLE SODIUM", "labeler_name": "Piramal Critical Care", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANTOPRAZOLE SODIUM", "brand_name_suffix": "I.V.", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/10mL"}], "application_number": "ANDA214680", "marketing_category": "ANDA", "marketing_start_date": "20231010", "listing_expiration_date": "20261231"}