FDA.reportPublic FDA data

Flucytosine

Product NDC
23155-861
11-digit product format
231550861
Labeler code
23155
Product ID
23155-861_7d6257c5-ed02-4f43-ba99-dece1e71fce3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flucytosine
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA212632
Marketing category
ANDA
Marketing start
2023-06-25
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
Flucytosine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUCYTOSINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD83282DT06
Rxcui197702, 197703

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
23155-861-01Flucytosine100 in 1 BOTTLECAPSULE1002
23155-861-03Flucytosine30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-861-01EA - Each23155-861eaddc0bf-1eac-42e8-98e4-fd80adb0101012023-09-05
23155-861-03EA - Each23155-8617ec2376e-5628-4333-973b-6ced5811315012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-861FLUCYTOSINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, 2 package rows20230625_f4c63d98-f03f-43f5-8c1f-e9ac6087312b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197702flucytosine 250 MG Oral CapsulePSNf4c63d98-f03f-43f5-8c1f-e9ac6087312b2
197703flucytosine 500 MG Oral CapsulePSNf4c63d98-f03f-43f5-8c1f-e9ac6087312b2
197702flucytosine 250 MG Oral CapsuleSCDf4c63d98-f03f-43f5-8c1f-e9ac6087312b2
197703flucytosine 500 MG Oral CapsuleSCDf4c63d98-f03f-43f5-8c1f-e9ac6087312b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-861-0123155086101100 CAPSULE in 1 BOTTLE (23155-861-01) 100 capsule2023-06-25NoNoHistorical
23155-861-032315508610330 CAPSULE in 1 BOTTLE (23155-861-03) 30 capsule2023-06-25NoNoHistorical