Flurbiprofen
These 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 useInitial U.S. Approval: 1988
Approved
Approval ID
4e5c06f1-f279-4f2f-b10d-0f70005a27e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2021
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flurbiprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-0711
Application NumberANDA074431
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flurbiprofen
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2021
FDA Product Classification
INGREDIENTS (13)
FLURBIPROFENActive
Quantity: 100 mg in 1 1
Code: 5GRO578KLP
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT