diflunisal

Generic: diflunisal

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diflunisal
Generic Name diflunisal
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diflunisal 500 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-9222
Product ID 0093-9222_673f00c6-1759-47a6-a098-fd61baf13d1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073673
Listing Expiration 2026-12-31
Marketing Start 2021-06-30

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 00939222
Hyphenated Format 0093-9222

Supplemental Identifiers

RxCUI
197603
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 ANDA073673 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (0093-9222-06)
source: ndc

Packages (3)

0093-9222-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01) 0093-9222-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05) 0093-9222-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-9222-06)

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": "673f00c6-1759-47a6-a098-fd61baf13d1e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["7C546U4DEN"], "rxcui": ["197603"], "spl_set_id": ["7a78bb38-14d8-4a90-b883-482d4cebf716"], "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": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01)", "package_ndc": "0093-9222-01", "marketing_start_date": "20210630"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05)", "package_ndc": "0093-9222-05", "marketing_start_date": "20220825"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0093-9222-06)", "package_ndc": "0093-9222-06", "marketing_start_date": "20210630"}], "brand_name": "Diflunisal", "product_id": "0093-9222_673f00c6-1759-47a6-a098-fd61baf13d1e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0093-9222", "generic_name": "Diflunisal", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diflunisal", "active_ingredients": [{"name": "DIFLUNISAL", "strength": "500 mg/1"}], "application_number": "ANDA073673", "marketing_category": "ANDA", "marketing_start_date": "20210630", "listing_expiration_date": "20261231"}