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 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-653
Product ID 71610-653_6c0bca16-d681-48d1-a07a-93d9d0f3acef
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 71610653
Hyphenated Format 71610-653

Supplemental Identifiers

RxCUI
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 (source: ndc)
Application Number ANDA202882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-53)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-60)
  • 180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-80)
source: ndc

Packages (4)

71610-653-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-30) 71610-653-53 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-53) 71610-653-60 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-60) 71610-653-80 180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-80)

Ingredients (1)

pantoprazole sodium (40 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": "6c0bca16-d681-48d1-a07a-93d9d0f3acef", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["314200"], "spl_set_id": ["e3f711d8-b9d3-46a6-8bf9-6af1cc77003e"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-30)", "package_ndc": "71610-653-30", "marketing_start_date": "20220714"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-53)", "package_ndc": "71610-653-53", "marketing_start_date": "20220714"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-60)", "package_ndc": "71610-653-60", "marketing_start_date": "20220714"}, {"sample": false, "description": "180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-653-80)", "package_ndc": "71610-653-80", "marketing_start_date": "20220714"}], "brand_name": "PANTOPRAZOLE SODIUM", "product_id": "71610-653_6c0bca16-d681-48d1-a07a-93d9d0f3acef", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71610-653", "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": "40 mg/1"}], "application_number": "ANDA202882", "marketing_category": "ANDA", "marketing_start_date": "20220501", "listing_expiration_date": "20261231"}