CycloSPORINE, Modfied
Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) Rx only
Approved
Approval ID
5baaf78c-90f6-abcf-52c8-814490f3cf9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 3
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 Code60505-4631
Application NumberANDA210721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification
INGREDIENTS (11)
CYCLOSPORINEActive
Quantity: 50 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)Inactive
Code: 0K9R94573C
Classification: IACT
PROPYLENE GLYCOL MONOLAURATEInactive
Code: 668Z5835Z3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROLYZED PORCINE COLLAGEN (ENZYMATIC; 3000 MW)Inactive
Code: 0K9R94573C
Classification: IACT
Cyclosporine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4632
Application NumberANDA210721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification
INGREDIENTS (11)
CYCLOSPORINEActive
Quantity: 100 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)Inactive
Code: 0K9R94573C
Classification: IACT
PROPYLENE GLYCOL MONOLAURATEInactive
Code: 668Z5835Z3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
HYDROLYZED PORCINE COLLAGEN (ENZYMATIC; 3000 MW)Inactive
Code: 0K9R94573C
Classification: IACT
Cyclosporine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-4630
Application NumberANDA210721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclosporine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification
INGREDIENTS (11)
CYCLOSPORINEActive
Quantity: 25 mg in 1 1
Code: 83HN0GTJ6D
Classification: ACTIB
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)Inactive
Code: 0K9R94573C
Classification: IACT
PROPYLENE GLYCOL MONOLAURATEInactive
Code: 668Z5835Z3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
HYDROLYZED PORCINE COLLAGEN (ENZYMATIC; 3000 MW)Inactive
Code: 0K9R94573C
Classification: IACT