Flurbiprofen Sodium
Flurbiprofen Sodium Ophthalmic Solution USP, 0.03%
Approved
Approval ID
725fb4ac-3bd2-4c0f-829f-a3a40863ebce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flurbiprofen Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-615
Application NumberANDA074447
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flurbiprofen Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 4, 2008
FDA Product Classification
INGREDIENTS (11)
Citric AcidInactive
Code: 2968PHW8QP
Classification: IACT
Flurbiprofen SodiumActive
Quantity: 0.242 mg in 1 mL
Code: Z5B97MU9K4
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
Potassium ChlorideInactive
Code: 660YQ98I10
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
ThimerosalInactive
Code: 2225PI3MOV
Classification: IACT