Flurbiprofen

Product NDC
0093-0711
11-digit product format
000930711
Labeler code
0093
Product ID
0093-0711_ea4b1dbf-08e4-442d-a281-4c51712494b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurbiprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074431
Marketing category
ANDA
Marketing start
1995-06-02
Marketing end
0000-00-00
Substance
FLURBIPROFEN
Active strength
100 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0711-01EA - Each0093-07118335407a-20f3-441d-aa22-8c952496a81412012-07-24
0093-0711-05EA - Each0093-07116b7aa0d3-a234-4210-b6df-763eda7eaf3812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLURBIPROFENACTIVE INGREDIENT5GRO578KLPFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
FLURBIPROFENACTIVE MOIETY5GRO578KLPFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0711FLURBIPROFEN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]14Legacy NDC20241208_4e5c06f1-f279-4f2f-b10d-0f70005a27e6.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
197724flurbiprofen 100 MG Oral TabletPSN745337de-5378-4f1d-b457-d2f45f2df665103
197724flurbiprofen 100 MG Oral TabletSCD745337de-5378-4f1d-b457-d2f45f2df665103
197724flurbiprofen 100 MG Oral TabletPSN6c6a0daa-de1b-5455-e053-2991aa0a4cf86
197724flurbiprofen 100 MG Oral TabletSCD6c6a0daa-de1b-5455-e053-2991aa0a4cf86
197724flurbiprofen 100 MG Oral TabletPSNc7911338-4071-f1d2-e053-2995a90a903d1
197724flurbiprofen 100 MG Oral TabletSCDc7911338-4071-f1d2-e053-2995a90a903d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-0711-0100093071101100 TABLET, FILM COATED in 1 BOTTLE (0093-0711-01) 1995-06-020000-00-00NoNoCurrent
0093-0711-0500093071105500 TABLET, FILM COATED in 1 BOTTLE (0093-0711-05) 1995-06-020000-00-00NoNoCurrent