Ciclopirox Olamine
Ciclopirox Olamine Cream USP, 0.77%
Approved
Approval ID
6d02fb24-9736-4fe3-b909-1b2172aa2773
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 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.
Ciclopirox Olamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8624
Application NumberANDA077364
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox Olamine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (11)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
MYRISTYL ALCOHOLInactive
Code: V42034O9PU
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
CICLOPIROX OLAMINEActive
Quantity: 7.7 mg in 1 g
Code: 50MD4SB4AP
Classification: ACTIM
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT