Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Novel Laboratories, Inc.
793518643
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novel Laboratories, Inc.
Novel Laboratories, Inc.
Novel Laboratories, Inc.
793518643
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
40032-771Application Number
ANDA204652Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 6, 2022FlucytosineActive
Code: D83282DT06Class: ACTIBQuantity: 250 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
Flucytosine
Product Details
NDC Product Code
40032-770Application Number
ANDA204652Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 6, 2022FlucytosineActive
Code: D83282DT06Class: ACTIBQuantity: 500 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Flucytosine Capsules USP, 250 mg
30 Capsules
Flucytosine Capsules USP, 500 mg
100 Capsules
