Desonide
Desonide Cream, 0.05% Desonide Ointment, 0.05%
Approved
Approval ID
6cea3912-23ae-45f3-b535-6fea29c7594f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 2
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 Code51672-1280
Application NumberANDA073548
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (11)
DesonideActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
aluminum subacetateInactive
Code: FGL8577C9S
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
sodium cetostearyl sulfateInactive
Code: 7ZBS06BH4B
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT
Desonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-1281
Application NumberANDA074254
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (3)
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
DesonideActive
Quantity: 0.5 mg in 1 g
Code: J280872D1O
Classification: ACTIB
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 1/31/2023
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by:Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: June, 2020
20769-0620-3
46