diflunisal

Generic: diflunisal

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diflunisal
Generic Name diflunisal
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diflunisal 500 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1083
Product ID 70771-1083_d5395b92-79af-436c-82ac-a6b70cd3b139
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 707711083
Hyphenated Format 70771-1083

Supplemental Identifiers

RxCUI
197603
UPC
0370771108312
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
  • 1000 TABLET in 1 BOTTLE (70771-1083-0)
  • 100 TABLET in 1 BOTTLE (70771-1083-1)
  • 30 TABLET in 1 BOTTLE (70771-1083-3)
  • 500 TABLET in 1 BOTTLE (70771-1083-5)
  • 60 TABLET in 1 BOTTLE (70771-1083-6)
  • 10 BLISTER PACK in 1 CARTON (70771-1083-8) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (70771-1083-9)
source: ndc

Packages (7)

70771-1083-0 1000 TABLET in 1 BOTTLE (70771-1083-0) 70771-1083-1 100 TABLET in 1 BOTTLE (70771-1083-1) 70771-1083-3 30 TABLET in 1 BOTTLE (70771-1083-3) 70771-1083-5 500 TABLET in 1 BOTTLE (70771-1083-5) 70771-1083-6 60 TABLET in 1 BOTTLE (70771-1083-6) 70771-1083-8 10 BLISTER PACK in 1 CARTON (70771-1083-8) / 10 TABLET in 1 BLISTER PACK 70771-1083-9 90 TABLET in 1 BOTTLE (70771-1083-9)

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": "d5395b92-79af-436c-82ac-a6b70cd3b139", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0370771108312"], "unii": ["7C546U4DEN"], "rxcui": ["197603"], "spl_set_id": ["d7a722be-4612-4b2e-827d-56fb5eef0aae"], "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 Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1083-0)", "package_ndc": "70771-1083-0", "marketing_start_date": "20170914"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1083-1)", "package_ndc": "70771-1083-1", "marketing_start_date": "20170914"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1083-3)", "package_ndc": "70771-1083-3", "marketing_start_date": "20170914"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1083-5)", "package_ndc": "70771-1083-5", "marketing_start_date": "20170914"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (70771-1083-6)", "package_ndc": "70771-1083-6", "marketing_start_date": "20170914"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1083-8)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70771-1083-8", "marketing_start_date": "20170914"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70771-1083-9)", "package_ndc": "70771-1083-9", "marketing_start_date": "20170914"}], "brand_name": "Diflunisal", "product_id": "70771-1083_d5395b92-79af-436c-82ac-a6b70cd3b139", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70771-1083", "generic_name": "Diflunisal", "labeler_name": "Zydus Lifesciences Limited", "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"}