flucytosine
Flucytosine Capsules, USP Rx only
Approved
Approval ID
46491f0f-7b34-4474-be46-5898b3b5b4c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
flucytosine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0427
Application NumberANDA206550
Product Classification
M
Marketing Category
C73584
G
Generic Name
flucytosine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2022
FDA Product Classification
INGREDIENTS (13)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FLUCYTOSINEActive
Quantity: 250 mg in 1 1
Code: D83282DT06
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
flucytosine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0428
Application NumberANDA206550
Product Classification
M
Marketing Category
C73584
G
Generic Name
flucytosine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2022
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FLUCYTOSINEActive
Quantity: 500 mg in 1 1
Code: D83282DT06
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT