pantoprazole sodium

Generic: pantoprazole sodium

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium
Labeler major pharmaceuticals
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pantoprazole sodium 20 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7458
Product ID 0904-7458_7f8bdcaa-2a4b-4ed0-a649-a528b3b278a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202038
Listing Expiration 2027-12-31
Marketing Start 2024-10-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047458
Hyphenated Format 0904-7458

Supplemental Identifiers

RxCUI
251872 314200
UNII
6871619Q5X

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 ANDA202038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7458-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7458-61 100 BLISTER PACK in 1 CARTON (0904-7458-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

pantoprazole sodium (20 mg/1)

Linked Drug Pages (1)

Pantoprazole Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7f8bdcaa-2a4b-4ed0-a649-a528b3b278a6", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["de419aa0-caa9-40fb-bc6d-e341c94273c7"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7458-61)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7458-61", "marketing_start_date": "20241007"}], "brand_name": "Pantoprazole Sodium", "product_id": "0904-7458_7f8bdcaa-2a4b-4ed0-a649-a528b3b278a6", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0904-7458", "generic_name": "Pantoprazole Sodium", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA202038", "marketing_category": "ANDA", "marketing_start_date": "20241007", "listing_expiration_date": "20271231"}