Flucytosine

Product NDC
0904-6834
11-digit product format
009046834
Labeler code
0904
Product ID
0904-6834_f6d603f8-d4ee-4541-928a-eb81b26bd4db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flucytosine
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA204652
Marketing category
ANDA
Marketing start
2017-07-07
Substance
FLUCYTOSINE
Active strength
250 mg/1
Pharmacologic classes
Nucleoside Analog Antifungal [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flucytosine
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4cbbebe-6acb-b5dc-a199-fda613aaf07bProduct name520200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6834-07Flucytosine30 in 1 CARTONCAPSULE307
0904-6834-07Flucytosine1 in 1 BLISTER PACKCAPSULE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6834-07EA - Each0904-683461d17d8e-f957-40fe-b3c7-69df8ca894c612019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6834FLUCYTOSINE CAPSULE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250330_01d874f9-e073-4092-94ad-da361551d4bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197702flucytosine 250 MG Oral CapsulePSN01d874f9-e073-4092-94ad-da361551d4bf7
197703flucytosine 500 MG Oral CapsulePSN01d874f9-e073-4092-94ad-da361551d4bf7
197702flucytosine 250 MG Oral CapsuleSCD01d874f9-e073-4092-94ad-da361551d4bf7
197703flucytosine 500 MG Oral CapsuleSCD01d874f9-e073-4092-94ad-da361551d4bf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6834-070090468340730 BLISTER PACK in 1 CARTON (0904-6834-07) / 1 CAPSULE in 1 BLISTER PACK30 blister pack2017-07-070000-00-00NoNoCurrent