pantoprazole

Generic: pantoprazole

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole
Generic Name pantoprazole
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pantoprazole sodium 20 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0552
Product ID 80425-0552_4136d849-f075-057c-e063-6394a90a91f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077619
Listing Expiration 2026-12-31
Marketing Start 2025-10-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250552
Hyphenated Format 80425-0552

Supplemental Identifiers

RxCUI
251872
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 (source: ndc)
Generic Name pantoprazole (source: ndc)
Application Number ANDA077619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-1)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-2)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-3)
source: ndc

Packages (3)

80425-0552-1 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-1) 80425-0552-2 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-2) 80425-0552-3 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-3)

Ingredients (1)

pantoprazole sodium (20 mg/1)

Linked Drug Pages (1)

Pantoprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4136d849-f075-057c-e063-6394a90a91f1", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872"], "spl_set_id": ["4136d983-75fa-9604-e063-6294a90aaac6"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-1)", "package_ndc": "80425-0552-1", "marketing_start_date": "20251015"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-2)", "package_ndc": "80425-0552-2", "marketing_start_date": "20251015"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0552-3)", "package_ndc": "80425-0552-3", "marketing_start_date": "20251015"}], "brand_name": "Pantoprazole", "product_id": "80425-0552_4136d849-f075-057c-e063-6394a90a91f1", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "80425-0552", "generic_name": "Pantoprazole", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA077619", "marketing_category": "ANDA", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}