Calcipotriene and Betamethasone Dipropionate
These highlights do not include all the information needed to use Calcipotriene and Betamethasone Dipropionate Ointment safely and effectively. See Full Prescribing Information for Calcipotriene and Betamethasone Dipropionate Ointment. Calcipotriene and Betamethasone Dipropionate Ointment, for topical useInitial U.S. Approval: 2006
Approved
Approval ID
d9493e66-251c-426c-90a8-1bf1e526ab85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2022
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcipotriene and Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-938
Application NumberNDA021852
Product Classification
M
Marketing Category
C73605
G
Generic Name
Calcipotriene and Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (7)
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
POLYPROPYLENE GLYCOL 11 STEARYL ETHERInactive
Code: S4G2J0Y0LG
Classification: IACT
CALCIPOTRIENE MONOHYDRATEActive
Quantity: 50 ug in 1 g
Code: S7499TYY6G
Classification: ACTIM