Flucytosine
Flucytosine Capsules, USP Rx Only 8459901/0822F
Approved
Approval ID
4b1c40b2-e0fb-47d5-b821-889b3090cebe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-610
Application NumberANDA213665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flucytosine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2022
FDA Product Classification
INGREDIENTS (10)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FLUCYTOSINEActive
Quantity: 500 mg in 1 1
Code: D83282DT06
Classification: ACTIB
Flucytosine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-599
Application NumberANDA213665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flucytosine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2022
FDA Product Classification
INGREDIENTS (13)
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FLUCYTOSINEActive
Quantity: 250 mg in 1 1
Code: D83282DT06
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT