Calcipotriene and Betamethasone Dipropionate
These highlights do not include all the information needed to use safely and effectively. See Full Prescribing Information for . Initial U.S. Approval: 2006
Approved
Approval ID
174c5378-f2b9-4e9e-931a-4123137be62d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcipotriene, Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2520
Application NumberANDA200174
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcipotriene, Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 10, 2022
FDA Product Classification
INGREDIENTS (6)
CALCIPOTRIENEActive
Quantity: 50 ug in 1 g
Code: 143NQ3779B
Classification: ACTIB
BETAMETHASONE DIPROPIONATEActive
Quantity: .643 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PPG-15 STEARYL ETHERInactive
Code: 1II18XLS1L
Classification: IACT
.ALPHA.-TOCOPHEROL, DL-Inactive
Code: 7QWA1RIO01
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT