FLUCYTOSINE

Product NDC
59651-331
11-digit product format
596510331
Labeler code
59651
Product ID
59651-331_bf0234fe-1b94-44fb-a06d-86af5c5c07ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUCYTOSINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213665
Marketing category
ANDA
Marketing start
2020-05-01
Substance
FLUCYTOSINE
Active strength
250 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
FLUCYTOSINE250 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
59651-331-01FLUCYTOSINE100 in 1 BOTTLECAPSULE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-331FLUCYTOSINE CAPSULE [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20220304_8b55832c-6771-4f5b-9aef-f88a1d22795e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197702flucytosine 250 MG Oral CapsulePSN8b55832c-6771-4f5b-9aef-f88a1d22795e4
197703flucytosine 500 MG Oral CapsulePSN8b55832c-6771-4f5b-9aef-f88a1d22795e4
197702flucytosine 250 MG Oral CapsuleSCD8b55832c-6771-4f5b-9aef-f88a1d22795e4
197703flucytosine 500 MG Oral CapsuleSCD8b55832c-6771-4f5b-9aef-f88a1d22795e4
197702flucytosine 250 MG Oral CapsulePSN4b1c40b2-e0fb-47d5-b821-889b3090cebe3
197703flucytosine 500 MG Oral CapsulePSN4b1c40b2-e0fb-47d5-b821-889b3090cebe3
197702flucytosine 250 MG Oral CapsuleSCD4b1c40b2-e0fb-47d5-b821-889b3090cebe3
197703flucytosine 500 MG Oral CapsuleSCD4b1c40b2-e0fb-47d5-b821-889b3090cebe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-331-0159651033101100 CAPSULE in 1 BOTTLE (59651-331-01) 100 capsule2020-05-010000-00-00NoNoCurrent