flurbiprofen

Generic: flurbiprofen

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name flurbiprofen
Generic Name flurbiprofen
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

flurbiprofen 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8338
Product ID 63629-8338_b018b566-3288-430e-b430-2a2d37f8da9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074431
Listing Expiration 2026-12-31
Marketing Start 1995-06-02

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 636298338
Hyphenated Format 63629-8338

Supplemental Identifiers

RxCUI
197724
UNII
5GRO578KLP
NUI
N0000000160 M0001335 N0000175722

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 flurbiprofen (source: ndc)
Generic Name flurbiprofen (source: ndc)
Application Number ANDA074431 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-8338-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63629-8338-2)
source: ndc

Packages (2)

Ingredients (1)

flurbiprofen (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b018b566-3288-430e-b430-2a2d37f8da9d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["5GRO578KLP"], "rxcui": ["197724"], "spl_set_id": ["5352162c-d09f-42be-9760-9d4bdfbe7788"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-8338-1)", "package_ndc": "63629-8338-1", "marketing_start_date": "20211223"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63629-8338-2)", "package_ndc": "63629-8338-2", "marketing_start_date": "20200717"}], "brand_name": "Flurbiprofen", "product_id": "63629-8338_b018b566-3288-430e-b430-2a2d37f8da9d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63629-8338", "generic_name": "Flurbiprofen", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flurbiprofen", "active_ingredients": [{"name": "FLURBIPROFEN", "strength": "100 mg/1"}], "application_number": "ANDA074431", "marketing_category": "ANDA", "marketing_start_date": "19950602", "listing_expiration_date": "20261231"}