Desonide
Desonide Cream, 0.05%For Dermatologic Use OnlyNot For Ophthalmic UseRx Only
Approved
Approval ID
99955d05-1198-4cd6-b2b4-9c328e48c0b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 11, 2025
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Desonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-632
Application NumberANDA214396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 11, 2025
FDA Product Classification
INGREDIENTS (12)
DESONIDEActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
ALUMINUM SULFATEInactive
Code: 34S289N54E
Classification: IACT
CALCIUM ACETATEInactive
Code: Y882YXF34X
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
ICODEXTRINInactive
Code: 2NX48Z0A9G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT