pantoprazole sodium

Generic: pantoprazole

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pantoprazole sodium 40 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-637
Product ID 65162-637_774b587f-7d77-4d2e-97f6-2b19d8cec56a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205119
Listing Expiration 2026-12-31
Marketing Start 2016-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162637
Hyphenated Format 65162-637

Supplemental Identifiers

RxCUI
251872 314200
UPC
0365162637038
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 (source: ndc)
Application Number ANDA205119 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-03)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-09)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-11)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-50)
source: ndc

Packages (4)

65162-637-03 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-03) 65162-637-09 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-09) 65162-637-11 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-11) 65162-637-50 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-50)

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": "774b587f-7d77-4d2e-97f6-2b19d8cec56a", "openfda": {"upc": ["0365162637038"], "unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["f3ded82a-cf0d-4844-944a-75f9f9215ff0"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-03)", "package_ndc": "65162-637-03", "marketing_start_date": "20160620"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-09)", "package_ndc": "65162-637-09", "marketing_start_date": "20160620"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-11)", "package_ndc": "65162-637-11", "marketing_start_date": "20160620"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-637-50)", "package_ndc": "65162-637-50", "marketing_start_date": "20160620"}], "brand_name": "Pantoprazole Sodium", "product_id": "65162-637_774b587f-7d77-4d2e-97f6-2b19d8cec56a", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "65162-637", "generic_name": "Pantoprazole", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA205119", "marketing_category": "ANDA", "marketing_start_date": "20160620", "listing_expiration_date": "20261231"}