Triamcinolone Acetonide
Triamcinolone Acetonide Cream USPRx only
Approved
Approval ID
0f3f105c-5791-4115-ac4e-2a9dcb36c9ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2020
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-945
Application NumberANDA208763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (10)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-953
Application NumberANDA208763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (10)
TRIAMCINOLONE ACETONIDEActive
Quantity: 5 mg in 1 g
Code: F446C597KA
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Triamcinolone Acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-952
Application NumberANDA208763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (10)
TRIAMCINOLONE ACETONIDEActive
Quantity: 0.25 mg in 1 g
Code: F446C597KA
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT