pantoprazole sodium

Generic: pantoprazole

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

Drug Facts

Product Profile

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

pantoprazole sodium 20 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-671
Product ID 76420-671_13ac2fea-63be-66a4-e063-6394a90a7b6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202882
Listing Expiration 2026-12-31
Marketing Start 2014-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420671
Hyphenated Format 76420-671

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

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-01)
  • 10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-10)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-60)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-90)
source: ndc

Packages (5)

76420-671-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-01) 76420-671-10 10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-10) 76420-671-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-30) 76420-671-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-60) 76420-671-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-90)

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": "13ac2fea-63be-66a4-e063-6394a90a7b6b", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["3540d01c-da0e-477e-9e90-994b96deb1d6"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-01)", "package_ndc": "76420-671-01", "marketing_start_date": "20240313"}, {"sample": false, "description": "10 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-10)", "package_ndc": "76420-671-10", "marketing_start_date": "20240313"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-30)", "package_ndc": "76420-671-30", "marketing_start_date": "20240313"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-60)", "package_ndc": "76420-671-60", "marketing_start_date": "20240313"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-671-90)", "package_ndc": "76420-671-90", "marketing_start_date": "20240313"}], "brand_name": "PANTOPRAZOLE SODIUM", "product_id": "76420-671_13ac2fea-63be-66a4-e063-6394a90a7b6b", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "76420-671", "generic_name": "PANTOPRAZOLE", "labeler_name": "Asclemed USA, Inc.", "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": "20140910", "listing_expiration_date": "20261231"}