pantoprazole sodium

Generic: pantoprazole

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pantoprazole sodium 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8644
Product ID 68788-8644_752724a9-4a89-4f98-9da5-4675b7d269e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202882
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888644
Hyphenated Format 68788-8644

Supplemental Identifiers

RxCUI
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
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-1)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-3)
  • 60 TABLET, DELAYED RELEASE in 1 CARTON (68788-8644-6)
  • 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-8)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-9)
source: ndc

Packages (5)

68788-8644-1 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-1) 68788-8644-3 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-3) 68788-8644-6 60 TABLET, DELAYED RELEASE in 1 CARTON (68788-8644-6) 68788-8644-8 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-8) 68788-8644-9 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-9)

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": "752724a9-4a89-4f98-9da5-4675b7d269e5", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["314200"], "spl_set_id": ["5c14e2f3-625d-4089-a404-440b0ecf72e7"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-1)", "package_ndc": "68788-8644-1", "marketing_start_date": "20240501"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-3)", "package_ndc": "68788-8644-3", "marketing_start_date": "20240501"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 CARTON (68788-8644-6)", "package_ndc": "68788-8644-6", "marketing_start_date": "20240501"}, {"sample": false, "description": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-8)", "package_ndc": "68788-8644-8", "marketing_start_date": "20240501"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8644-9)", "package_ndc": "68788-8644-9", "marketing_start_date": "20240501"}], "brand_name": "PANTOPRAZOLE SODIUM", "product_id": "68788-8644_752724a9-4a89-4f98-9da5-4675b7d269e5", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68788-8644", "generic_name": "PANTOPRAZOLE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANTOPRAZOLE SODIUM", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA202882", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}