Clotrimazole
Clotrimazole
Approved
Approval ID
325a40b0-3e17-47c6-8988-d5396ca5d53f
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 23, 2025
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-2062
Application NumberNDA021143
Product Classification
M
Marketing Category
C73594
G
Generic Name
Clotrimazole
Product Specifications
Route of AdministrationVAGINAL
Effective DateApril 23, 2025
FDA Product Classification
INGREDIENTS (8)
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GU
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 2 g in 100 g
Code: G07GZ97H65
Classification: ACTIB