ANCOBON

Product NDC
0187-3555
11-digit product format
001873555
Labeler code
0187
Product ID
0187-3555_2611b6d9-1f11-4c1d-a2b6-ae818d39d299
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flucytosine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bausch Health US LLC
Application
NDA017001
Marketing category
NDA
Marketing start
1971-11-26
Substance
FLUCYTOSINE
Active strength
500 mg/1
Pharmacologic classes
Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANCOBON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCYTOSINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD83282DT06
Rxcui197702, 197703, 207125, 207127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4cbbebe-6acb-b5dc-a199-fda613aaf07bProduct name520200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-3555-10ANCOBON100 in 1 BOTTLECAPSULE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-3555-10EA - Each0187-355520109bd2-bec8-45ab-8b3c-56ea65e91b6f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FlucytosineACTIVE INGREDIENTD83282DT06ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
FlucytosineACTIVE MOIETYD83282DT06ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANCOBON (FLUCYTOSINE) CAPSULE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-3555ANCOBON (FLUCYTOSINE) CAPSULE [BAUSCH HEALTH US LLC]16Current NDC, Legacy NDC, 1 package rows20220513_aea0df00-a88c-4a16-abcf-750f3ff2004e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207125Ancobon 250 MG Oral CapsulePSNaea0df00-a88c-4a16-abcf-750f3ff2004e16
207127Ancobon 500 MG Oral CapsulePSNaea0df00-a88c-4a16-abcf-750f3ff2004e16
197702flucytosine 250 MG Oral CapsulePSNaea0df00-a88c-4a16-abcf-750f3ff2004e16
197703flucytosine 500 MG Oral CapsulePSNaea0df00-a88c-4a16-abcf-750f3ff2004e16
207125flucytosine 250 MG Oral Capsule [Ancobon]SBDaea0df00-a88c-4a16-abcf-750f3ff2004e16
207127flucytosine 500 MG Oral Capsule [Ancobon]SBDaea0df00-a88c-4a16-abcf-750f3ff2004e16
197702flucytosine 250 MG Oral CapsuleSCDaea0df00-a88c-4a16-abcf-750f3ff2004e16
197703flucytosine 500 MG Oral CapsuleSCDaea0df00-a88c-4a16-abcf-750f3ff2004e16
207125Ancobon 250 MG Oral CapsuleSYaea0df00-a88c-4a16-abcf-750f3ff2004e16
207127Ancobon 500 MG Oral CapsuleSYaea0df00-a88c-4a16-abcf-750f3ff2004e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-3555-1000187355510100 CAPSULE in 1 BOTTLE (0187-3555-10) 100 capsule1971-11-260000-00-00NoNoCurrent