pantoprazole sodium

Generic: pantoprazole sodium

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

Drug Facts

Product Profile

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

pantoprazole sodium 40 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6689
Product ID 0378-6689_38896560-f523-4d0b-8113-5ff7f5f38c81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090970
Listing Expiration 2026-12-31
Marketing Start 2011-01-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786689
Hyphenated Format 0378-6689

Supplemental Identifiers

RxCUI
251872 314200
UPC
0303786689774 0303786688777
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 ANDA090970 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-10)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-77)
source: ndc

Packages (2)

0378-6689-10 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-10) 0378-6689-77 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-77)

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": "38896560-f523-4d0b-8113-5ff7f5f38c81", "openfda": {"upc": ["0303786689774", "0303786688777"], "unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["56ad5b97-8e5f-48a5-b2ba-a5484b43d018"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-10)", "package_ndc": "0378-6689-10", "marketing_start_date": "20110119"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-77)", "package_ndc": "0378-6689-77", "marketing_start_date": "20110119"}], "brand_name": "Pantoprazole Sodium", "product_id": "0378-6689_38896560-f523-4d0b-8113-5ff7f5f38c81", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0378-6689", "generic_name": "pantoprazole sodium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA090970", "marketing_category": "ANDA", "marketing_start_date": "20110119", "listing_expiration_date": "20261231"}