pantoprazole sodium

Generic: pantoprazole sodium

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pantoprazole sodium 20 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-585
Product ID 50268-585_4510e1ae-df21-156c-e063-6394a90a09da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078281
Listing Expiration 2026-12-31
Marketing Start 2021-01-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268585
Hyphenated Format 50268-585

Supplemental Identifiers

RxCUI
251872
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 ANDA078281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-585-15) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-585-11)
source: ndc

Packages (1)

50268-585-15 50 BLISTER PACK in 1 BOX (50268-585-15) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-585-11)

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": "4510e1ae-df21-156c-e063-6394a90a09da", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872"], "spl_set_id": ["b9fa8381-b75e-b1cd-e053-2a95a90a9883"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-585-15)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-585-11)", "package_ndc": "50268-585-15", "marketing_start_date": "20210128"}], "brand_name": "Pantoprazole Sodium", "product_id": "50268-585_4510e1ae-df21-156c-e063-6394a90a09da", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "50268-585", "generic_name": "Pantoprazole Sodium", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA078281", "marketing_category": "ANDA", "marketing_start_date": "20210128", "listing_expiration_date": "20261231"}