pantoprazole sodium

Generic: pantoprazole sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium
Labeler aurobindo pharma limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pantoprazole sodium 40 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-560
Product ID 65862-560_4784124c-9df4-42f6-8044-c0480c1a3bbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202038
Listing Expiration 2027-12-31
Marketing Start 2012-09-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862560
Hyphenated Format 65862-560

Supplemental Identifiers

RxCUI
251872 314200
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 sodium (source: ndc)
Application Number ANDA202038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-05)
  • 10 BLISTER PACK in 1 CARTON (65862-560-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-90)
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-99)
source: ndc

Packages (4)

65862-560-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-05) 65862-560-10 10 BLISTER PACK in 1 CARTON (65862-560-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK 65862-560-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-90) 65862-560-99 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-99)

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": "4784124c-9df4-42f6-8044-c0480c1a3bbf", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["7418f358-f536-4de6-adf0-562b4373f2e3"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-05)", "package_ndc": "65862-560-05", "marketing_start_date": "20251204"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-560-10)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "65862-560-10", "marketing_start_date": "20120928"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-90)", "package_ndc": "65862-560-90", "marketing_start_date": "20120928"}, {"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-560-99)", "package_ndc": "65862-560-99", "marketing_start_date": "20120928"}], "brand_name": "Pantoprazole Sodium", "product_id": "65862-560_4784124c-9df4-42f6-8044-c0480c1a3bbf", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "65862-560", "generic_name": "Pantoprazole Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA202038", "marketing_category": "ANDA", "marketing_start_date": "20120928", "listing_expiration_date": "20271231"}