Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bausch Health Companies Inc.
Cameron Pharmaceuticals, LLC
253292734
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flucytosine
Product Details
NDC Product Code
42494-339Application Number
NDA017001Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
October 5, 2022FlucytosineActive
Code: D83282DT06Class: ACTIBQuantity: 250 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
Flucytosine
Product Details
NDC Product Code
42494-340Application Number
NDA017001Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
October 5, 2022FlucytosineActive
Code: D83282DT06Class: ACTIBQuantity: 500 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT