Dexamethasone Sodium Phosphate
Dexamethasone SodiumPhosphate Ophthalmic Solution, USPEquivalent to dexamethasone phosphate 0.1%STERILE
Approved
Approval ID
a2c2385e-74a8-4a18-92ec-be8a1380e13a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 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.
dexamethasone sodium phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-847
Application NumberANDA088771
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexamethasone sodium phosphate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 5, 2007
FDA Product Classification
INGREDIENTS (7)
dexamethasone sodium phosphateActive
Quantity: 1 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT