Dexamethasone Sodium Phosphate
Approved
Approval ID
c7700945-e498-4f01-9719-83cee899860d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3129
Application NumberANDA088771
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 13, 2011
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
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT