Flurbiprofen

Product NDC
63629-8338
11-digit product format
636298338
Labeler code
63629
Product ID
63629-8338_b018b566-3288-430e-b430-2a2d37f8da9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurbiprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8338-1Flurbiprofen30 in 1 BOTTLETABLET, FILM COATED301004
63629-8338-2Flurbiprofen60 in 1 BOTTLETABLET, FILM COATED601004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8338FLURBIPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]1004Current NDC, Legacy NDC, 2 package rows20231109_5352162c-d09f-42be-9760-9d4bdfbe7788.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197724flurbiprofen 100 MG Oral TabletPSN5352162c-d09f-42be-9760-9d4bdfbe77881004
197724flurbiprofen 100 MG Oral TabletSCD5352162c-d09f-42be-9760-9d4bdfbe77881004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8338-16362983380130 TABLET, FILM COATED in 1 BOTTLE (63629-8338-1) 2021-12-230000-00-00NoNoCurrent
63629-8338-26362983380260 TABLET, FILM COATED in 1 BOTTLE (63629-8338-2) 2020-07-170000-00-00NoNoCurrent