diflunisal

Generic: diflunisal

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

Drug Facts

Product Profile

Brand Name diflunisal
Generic Name diflunisal
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diflunisal 500 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-456
Product ID 62135-456_242086f3-3373-fac8-e063-6394a90a82ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202845
Listing Expiration 2026-12-31
Marketing Start 2012-03-08

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135456
Hyphenated Format 62135-456

Supplemental Identifiers

RxCUI
197603
UPC
0362135456603
UNII
7C546U4DEN
NUI
N0000000160 M0001335 N0000175722

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 diflunisal (source: ndc)
Generic Name diflunisal (source: ndc)
Application Number ANDA202845 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (62135-456-60)
source: ndc

Packages (1)

62135-456-60 60 TABLET, FILM COATED in 1 BOTTLE (62135-456-60)

Ingredients (1)

diflunisal (500 mg/1)

Linked Drug Pages (1)

Diflunisal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "242086f3-3373-fac8-e063-6394a90a82ab", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0362135456603"], "unii": ["7C546U4DEN"], "rxcui": ["197603"], "spl_set_id": ["2043bab8-87c9-45ce-88c7-383f0d4c4b64"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (62135-456-60)", "package_ndc": "62135-456-60", "marketing_start_date": "20230131"}], "brand_name": "Diflunisal", "product_id": "62135-456_242086f3-3373-fac8-e063-6394a90a82ab", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "62135-456", "generic_name": "Diflunisal", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diflunisal", "active_ingredients": [{"name": "DIFLUNISAL", "strength": "500 mg/1"}], "application_number": "ANDA202845", "marketing_category": "ANDA", "marketing_start_date": "20120308", "listing_expiration_date": "20261231"}