pantoprazole sodium

Generic: pantoprazole sodium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium
Labeler asclemed usa, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pantoprazole sodium 40 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-806
Product ID 76420-806_1767ddff-d487-6d80-e063-6294a90a1835
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202038
Listing Expiration 2026-12-31
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 76420806
Hyphenated Format 76420-806

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-10)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-60)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-90)
source: ndc

Packages (4)

76420-806-10 10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-10) 76420-806-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-30) 76420-806-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-60) 76420-806-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-90)

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": "1767ddff-d487-6d80-e063-6294a90a1835", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["138b30cb-6b28-450e-9e7a-42576cc76545"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-10)", "package_ndc": "76420-806-10", "marketing_start_date": "20240501"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-30)", "package_ndc": "76420-806-30", "marketing_start_date": "20240501"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-60)", "package_ndc": "76420-806-60", "marketing_start_date": "20240501"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-806-90)", "package_ndc": "76420-806-90", "marketing_start_date": "20240501"}], "brand_name": "Pantoprazole Sodium", "product_id": "76420-806_1767ddff-d487-6d80-e063-6294a90a1835", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "76420-806", "generic_name": "Pantoprazole Sodium", "labeler_name": "Asclemed USA, Inc.", "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": "20261231"}