Dexamethasone Sodium Phosphate
Dexamethasone Sodium Phosphate Ophthalmic Solution USP, 0.1% Dexamethasone Phosphate Equivalent(Sterile)
Approved
Approval ID
b61aec30-66c0-4abe-a8ad-2d98d88f21b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 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.
Dexamethasone Sodium Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-088
Application NumberANDA040069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone Sodium Phosphate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 30, 2010
FDA Product Classification
INGREDIENTS (11)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CREATININEInactive
Code: AYI8EX34EU
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
DEXAMETHASONE SODIUM PHOSPHATEActive
Quantity: 1 mg in 1 mL
Code: AI9376Y64P
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6I
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT