pantoprazole sodium

Generic: pantoprazole sodium

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pantoprazole sodium 40 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-534
Product ID 62135-534_4687aefe-4974-b8d6-e063-6294a90a0522
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078281
Listing Expiration 2026-12-31
Marketing Start 2011-01-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135534
Hyphenated Format 62135-534

Supplemental Identifiers

RxCUI
251872 314200
UPC
0362135534905 0362135533908 0362135534080
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 ANDA078281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 450 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-08)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-90)
source: ndc

Packages (2)

62135-534-08 450 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-08) 62135-534-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-90)

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": "4687aefe-4974-b8d6-e063-6294a90a0522", "openfda": {"upc": ["0362135534905", "0362135533908", "0362135534080"], "unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["42a969c3-1144-4151-9cf3-3e9bace6a380"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "450 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-08)", "package_ndc": "62135-534-08", "marketing_start_date": "20230405"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-534-90)", "package_ndc": "62135-534-90", "marketing_start_date": "20230405"}], "brand_name": "Pantoprazole Sodium", "product_id": "62135-534_4687aefe-4974-b8d6-e063-6294a90a0522", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "62135-534", "generic_name": "Pantoprazole Sodium", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA078281", "marketing_category": "ANDA", "marketing_start_date": "20110120", "listing_expiration_date": "20261231"}