diflunisal

Generic: diflunisal

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diflunisal
Generic Name diflunisal
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diflunisal 500 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 14539-673
Product ID 14539-673_0f1ed721-7842-4b8e-9f10-cf697531e750
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 14539673
Hyphenated Format 14539-673

Supplemental Identifiers

RxCUI
197602 197603 249400
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
  • 100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (14539-673-06)
source: ndc

Packages (3)

14539-673-01 100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01) 14539-673-05 500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05) 14539-673-06 60 TABLET, FILM COATED in 1 BOTTLE (14539-673-06)

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": "0f1ed721-7842-4b8e-9f10-cf697531e750", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["7C546U4DEN"], "rxcui": ["197602", "197603", "249400"], "spl_set_id": ["666f89b4-fd81-420a-a390-eb1cd4014f61"], "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": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01)", "package_ndc": "14539-673-01", "marketing_start_date": "20190109"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05)", "package_ndc": "14539-673-05", "marketing_start_date": "20190109"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (14539-673-06)", "package_ndc": "14539-673-06", "marketing_start_date": "20190109"}], "brand_name": "diflunisal", "product_id": "14539-673_0f1ed721-7842-4b8e-9f10-cf697531e750", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "14539-673", "generic_name": "diflunisal", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "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"}