FDA.reportPublic FDA data

Flurbiprofen

Product NDC
68071-4436
11-digit product format
680714436
Labeler code
68071
Product ID
68071-4436_1a8c403f-badb-36b1-e063-6394a90a18d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurbiprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA074431
Marketing category
ANDA
Marketing start
1995-06-02
Substance
FLURBIPROFEN
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flurbiprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURBIPROFEN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5GRO578KLP
Rxcui197724

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4de25cad-9156-ffae-eb2b-85736b333948Product name220201015
4d57173b-5512-6c00-533c-5ed2a40fc5b8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4436-42024-06-10C16284748780-1ba0f9c33-1009-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
68071-4436-42023-01-30C16284748780-1ba0f9c33-1009-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
68071-4436-42021-02-16C16284748780-1ba0f9c33-1009-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988
68071-4436-42021-01-29C16284748780-1ba0f9c33-1009-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use FLURBIPROFEN TABLETS safely and effectively. See full prescribing information for FLURBIPROFEN TABLETS. FLURBIPROFEN tablets, for oral use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4436-4Flurbiprofen14 in 1 BOTTLETABLET, FILM COATED146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4436FLURBIPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20240612_6c6a0daa-de1b-5455-e053-2991aa0a4cf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197724flurbiprofen 100 MG Oral TabletPSN6c6a0daa-de1b-5455-e053-2991aa0a4cf86
197724flurbiprofen 100 MG Oral TabletSCD6c6a0daa-de1b-5455-e053-2991aa0a4cf86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4436-46807144360414 TABLET, FILM COATED in 1 BOTTLE (68071-4436-4) 2018-05-170000-00-00NoNoCurrent