dolobid

Generic: diflunisal

Labeler: ina pharmaceutics inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dolobid
Generic Name diflunisal
Labeler ina pharmaceutics inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diflunisal 375 mg/1

Manufacturer
INA Pharmaceutics Inc

Identifiers & Regulatory

Product NDC 74157-101
Product ID 74157-101_4081e337-1003-6e39-e063-6294a90a4698
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202845
Listing Expiration 2026-12-31
Marketing Start 2024-08-19

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 74157101
Hyphenated Format 74157-101

Supplemental Identifiers

RxCUI
105823 197602 249400 2691103
UPC
0374157101607 0374157009606
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 dolobid (source: ndc)
Generic Name diflunisal (source: ndc)
Application Number ANDA202845 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 375 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (74157-101-60)
source: ndc

Packages (1)

74157-101-60 60 TABLET, FILM COATED in 1 BOTTLE (74157-101-60)

Ingredients (1)

diflunisal (375 mg/1)

Linked Drug Pages (1)

Dolobid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4081e337-1003-6e39-e063-6294a90a4698", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0374157101607", "0374157009606"], "unii": ["7C546U4DEN"], "rxcui": ["105823", "197602", "249400", "2691103"], "spl_set_id": ["725234b2-0e23-45c3-a42d-eb4e62273f9b"], "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": ["INA Pharmaceutics Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (74157-101-60)", "package_ndc": "74157-101-60", "marketing_start_date": "20240819"}], "brand_name": "Dolobid", "product_id": "74157-101_4081e337-1003-6e39-e063-6294a90a4698", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "74157-101", "generic_name": "Diflunisal", "labeler_name": "INA Pharmaceutics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dolobid", "active_ingredients": [{"name": "DIFLUNISAL", "strength": "375 mg/1"}], "application_number": "ANDA202845", "marketing_category": "ANDA", "marketing_start_date": "20240819", "listing_expiration_date": "20261231"}