Triamcinolone Acetonide
Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% Rx only
Approved
Approval ID
5873c78d-a9d4-49fc-95b8-5d4a368e9109
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-328
Application NumberANDA209535
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (8)
TRIAMCINOLONE ACETONIDEActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-329
Application NumberANDA209535
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (8)
TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-327
Application NumberANDA209535
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (8)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 0.25 mg in 1 g
Code: F446C597KA
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT