Amcinonide
Amcinonide Cream USP, 0.1% Amcinonide Ointment USP, 0.1%
Approved
Approval ID
ac5c3e79-52f7-434e-92ae-24bd32b45edc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
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.
Amcinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4054
Application NumberANDA076229
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amcinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMCINONIDEActive
Quantity: 1 mg in 1 g
Code: 423W026MA9
Classification: ACTIB
Amcinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4060
Application NumberANDA076367
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amcinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (7)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
AMCINONIDEActive
Quantity: 1 mg in 1 g
Code: 423W026MA9
Classification: ACTIB