diflunisal

Generic: diflunisal

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diflunisal
Generic Name diflunisal
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diflunisal 500 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-530
Product ID 68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203547
Listing Expiration 2026-12-31
Marketing Start 2017-09-14

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 68382530
Hyphenated Format 68382-530

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 ANDA203547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-530-01)
  • 500 TABLET in 1 BOTTLE (68382-530-05)
  • 30 TABLET in 1 BOTTLE (68382-530-06)
  • 1000 TABLET in 1 BOTTLE (68382-530-10)
  • 60 TABLET in 1 BOTTLE (68382-530-14)
  • 90 TABLET in 1 BOTTLE (68382-530-16)
  • 10 BLISTER PACK in 1 CARTON (68382-530-30) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (7)

68382-530-01 100 TABLET in 1 BOTTLE (68382-530-01) 68382-530-05 500 TABLET in 1 BOTTLE (68382-530-05) 68382-530-06 30 TABLET in 1 BOTTLE (68382-530-06) 68382-530-10 1000 TABLET in 1 BOTTLE (68382-530-10) 68382-530-14 60 TABLET in 1 BOTTLE (68382-530-14) 68382-530-16 90 TABLET in 1 BOTTLE (68382-530-16) 68382-530-30 10 BLISTER PACK in 1 CARTON (68382-530-30) / 10 TABLET in 1 BLISTER PACK

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": "15c3b31f-e781-4406-a5b4-56c653ecff80", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["7C546U4DEN"], "rxcui": ["197603"], "spl_set_id": ["5baf9f35-6b5e-4666-a14a-ac0f9d4e9f76"], "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": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-530-01)", "package_ndc": "68382-530-01", "marketing_start_date": "20170914"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-530-05)", "package_ndc": "68382-530-05", "marketing_start_date": "20170914"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-530-06)", "package_ndc": "68382-530-06", "marketing_start_date": "20170914"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-530-10)", "package_ndc": "68382-530-10", "marketing_start_date": "20170914"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68382-530-14)", "package_ndc": "68382-530-14", "marketing_start_date": "20170914"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-530-16)", "package_ndc": "68382-530-16", "marketing_start_date": "20170914"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-530-30)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68382-530-30", "marketing_start_date": "20170914"}], "brand_name": "Diflunisal", "product_id": "68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68382-530", "generic_name": "Diflunisal", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diflunisal", "active_ingredients": [{"name": "DIFLUNISAL", "strength": "500 mg/1"}], "application_number": "ANDA203547", "marketing_category": "ANDA", "marketing_start_date": "20170914", "listing_expiration_date": "20261231"}