FLURBIPROFEN SODIUM
Flurbiprofen SodiumOphthalmic Solution, USP 0.03%
Approved
Approval ID
043665e5-c6e0-4353-9933-6ba9e4860842
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2011
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 Code42254-023
Application NumberNDA019404
Product Classification
M
Marketing Category
C73605
G
Generic Name
flurbiprofen sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 2, 2011
FDA Product Classification
INGREDIENTS (11)
flurbiprofen sodiumActive
Quantity: 0.3 mg in 1 mL
Code: Z5B97MU9K4
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
thimerosalInactive
Code: 2225PI3MOV
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT