pantoprazole sodium

Generic: pantoprazole sodium

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pantoprazole sodium 40 mg/1

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-428
Product ID 35573-428_eb46c38e-b217-4295-9569-98c16cad56df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202038
Listing Expiration 2027-12-31
Marketing Start 2020-04-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573428
Hyphenated Format 35573-428

Supplemental Identifiers

RxCUI
314200
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 ANDA202038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (35573-428-80) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

35573-428-80 10 BLISTER PACK in 1 CARTON (35573-428-80) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK

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": "eb46c38e-b217-4295-9569-98c16cad56df", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["314200"], "spl_set_id": ["3cc5197e-6b39-4415-b963-d4bbeecd7953"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (35573-428-80)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "35573-428-80", "marketing_start_date": "20200420"}], "brand_name": "Pantoprazole Sodium", "product_id": "35573-428_eb46c38e-b217-4295-9569-98c16cad56df", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "35573-428", "generic_name": "Pantoprazole Sodium", "labeler_name": "Burel Pharmaceuticals, LLC", "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": "20200420", "listing_expiration_date": "20271231"}