Cyclosporine
CYCLOSPORINE CAPSULES, USP 25 mg and 100 mg Rx only
Approved
Approval ID
bfca7088-fe93-abb9-3ec3-e6f5710a69c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclosporine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-0133
Application NumberANDA065040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (15)
CYCLOSPORINEActive
Quantity: 25 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Cyclosporine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-0134
Application NumberANDA065040
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (15)
CYCLOSPORINEActive
Quantity: 100 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT