pantoprazole sodium

Generic: pantoprazole sodium injection

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium injection
Labeler alembic pharmaceuticals limited
Dosage Form POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pantoprazole sodium 40 mg/10mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-071
Product ID 46708-071_02ee7ed6-217f-4128-bbbb-b9390475a65b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219230
Listing Expiration 2026-12-31
Marketing Start 2025-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708071
Hyphenated Format 46708-071

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 injection (source: ndc)
Application Number ANDA219230 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (46708-071-01) / 10 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (46708-071-10) / 10 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (46708-071-25) / 10 mL in 1 VIAL
source: ndc

Packages (3)

46708-071-01 1 VIAL in 1 CARTON (46708-071-01) / 10 mL in 1 VIAL 46708-071-10 10 VIAL in 1 CARTON (46708-071-10) / 10 mL in 1 VIAL 46708-071-25 25 VIAL in 1 CARTON (46708-071-25) / 10 mL in 1 VIAL

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": "02ee7ed6-217f-4128-bbbb-b9390475a65b", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["283669"], "spl_set_id": ["02ee7ed6-217f-4128-bbbb-b9390475a65b"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (46708-071-01)  / 10 mL in 1 VIAL", "package_ndc": "46708-071-01", "marketing_start_date": "20250331"}, {"sample": false, "description": "10 VIAL in 1 CARTON (46708-071-10)  / 10 mL in 1 VIAL", "package_ndc": "46708-071-10", "marketing_start_date": "20250331"}, {"sample": false, "description": "25 VIAL in 1 CARTON (46708-071-25)  / 10 mL in 1 VIAL", "package_ndc": "46708-071-25", "marketing_start_date": "20250331"}], "brand_name": "PANTOPRAZOLE SODIUM", "product_id": "46708-071_02ee7ed6-217f-4128-bbbb-b9390475a65b", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "46708-071", "generic_name": "pantoprazole sodium injection", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANTOPRAZOLE SODIUM", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/10mL"}], "application_number": "ANDA219230", "marketing_category": "ANDA", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}