Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
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
60687-610Application Number
ANDA213665Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2022GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FlucytosineActive
Code: D83282DT06Class: ACTIBQuantity: 500 mg in 1 1
Flucytosine
Product Details
NDC Product Code
60687-599Application Number
ANDA213665Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 27, 2022POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FlucytosineActive
Code: D83282DT06Class: ACTIBQuantity: 250 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
STARCH, POTATOInactive
Code: 8I089SAH3TClass: IACT