Flurbiprofen Sodium
Flurbiprofen Sodium Ophthalmic Solution, USP 0.03% (Sterile)
Approved
Approval ID
8c5247a4-6388-44f4-8a47-3de5e7c5b169
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-937
Application NumberANDA074447
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flurbiprofen Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (11)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FLURBIPROFEN SODIUMActive
Quantity: 0.3 mg in 1 mL
Code: Z5B97MU9K4
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
THIMEROSALInactive
Code: 2225PI3MOV
Classification: IACT