pantoprazole sodium

Generic: pantoprazole

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pantoprazole sodium 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-659
Product ID 71610-659_269544ac-1dea-4047-87e6-6e04ff951b55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202882
Listing Expiration 2026-12-31
Marketing Start 2022-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610659
Hyphenated Format 71610-659

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 sodium (source: ndc)
Generic Name pantoprazole (source: ndc)
Application Number ANDA202882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 9000 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-09)
  • 1800 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-42)
source: ndc

Packages (2)

71610-659-09 9000 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-09) 71610-659-42 1800 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-42)

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": "269544ac-1dea-4047-87e6-6e04ff951b55", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872"], "spl_set_id": ["c10e9c12-e39d-4b0b-bd4c-10d3e9a4cf34"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-09)", "package_ndc": "71610-659-09", "marketing_start_date": "20220825"}, {"sample": false, "description": "1800 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-659-42)", "package_ndc": "71610-659-42", "marketing_start_date": "20230217"}], "brand_name": "PANTOPRAZOLE SODIUM", "product_id": "71610-659_269544ac-1dea-4047-87e6-6e04ff951b55", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71610-659", "generic_name": "PANTOPRAZOLE", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANTOPRAZOLE SODIUM", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA202882", "marketing_category": "ANDA", "marketing_start_date": "20220501", "listing_expiration_date": "20261231"}