Flucytosine

Product NDC
42794-009
11-digit product format
427940009
Labeler code
42794
Product ID
42794-009_f1f1b263-dcab-60e7-e053-2995a90ae493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flucytosine
Dosage form
CAPSULE
Route
ORAL
Labeler
Sigmapharm Laboratories, LLC
Application
ANDA201566
Marketing category
ANDA
Marketing start
2018-06-01
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
42794-009-08Flucytosine30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42794-009-08EA - Each42794-009ffb49f35-d78e-4710-bf5f-551378a4340812018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42794-009FLUCYTOSINE CAPSULE [SIGMAPHARM LABORATORIES, LLC]4Current NDC, Legacy NDC, 1 package rows20230111_3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197702flucytosine 250 MG Oral CapsulePSN3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e4
197703flucytosine 500 MG Oral CapsulePSN3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e4
197702flucytosine 250 MG Oral CapsuleSCD3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e4
197703flucytosine 500 MG Oral CapsuleSCD3f2f67a8-2d13-4a7c-8e90-8b625c6ed98e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42794-009-084279400090830 CAPSULE in 1 BOTTLE (42794-009-08) 30 capsule2018-06-010000-00-00NoNoCurrent