FDA.reportPublic FDA data

Flucytosine

Product NDC
43386-770
11-digit product format
433860770
Labeler code
43386
Product ID
43386-770_f404c3d3-ea62-4918-aebd-58b00b661bb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flucytosine
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA204652
Marketing category
ANDA
Marketing start
2017-07-07
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
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
43386-770-01Flucytosine100 in 1 BOTTLECAPSULE1007
43386-770-03Flucytosine30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-770-01EA - Each43386-770cf94ba9b-1ff4-4e21-8130-b1c4072c5f2912017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-770FLUCYTOSINE CAPSULE [LUPIN PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 2 package rows20250515_5721b46a-4a9f-46c2-8804-a9bad4d5f80a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197702flucytosine 250 MG Oral CapsulePSN01d874f9-e073-4092-94ad-da361551d4bf7
197702flucytosine 250 MG Oral CapsulePSN5721b46a-4a9f-46c2-8804-a9bad4d5f80a7
197703flucytosine 500 MG Oral CapsulePSN01d874f9-e073-4092-94ad-da361551d4bf7
197703flucytosine 500 MG Oral CapsulePSN5721b46a-4a9f-46c2-8804-a9bad4d5f80a7
197702flucytosine 250 MG Oral CapsuleSCD01d874f9-e073-4092-94ad-da361551d4bf7
197702flucytosine 250 MG Oral CapsuleSCD5721b46a-4a9f-46c2-8804-a9bad4d5f80a7
197703flucytosine 500 MG Oral CapsuleSCD01d874f9-e073-4092-94ad-da361551d4bf7
197703flucytosine 500 MG Oral CapsuleSCD5721b46a-4a9f-46c2-8804-a9bad4d5f80a7
197702flucytosine 250 MG Oral CapsulePSNbfc817db-ab65-5cd7-e053-2995a90a8ee84
197703flucytosine 500 MG Oral CapsulePSNbfc817db-ab65-5cd7-e053-2995a90a8ee84
197702flucytosine 250 MG Oral CapsuleSCDbfc817db-ab65-5cd7-e053-2995a90a8ee84
197703flucytosine 500 MG Oral CapsuleSCDbfc817db-ab65-5cd7-e053-2995a90a8ee84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-770-0143386077001100 CAPSULE in 1 BOTTLE (43386-770-01) 100 capsule2017-07-070000-00-00YesNoCurrent
43386-770-034338607700330 CAPSULE in 1 BOTTLE (43386-770-03) 30 capsule2017-07-070000-00-00NoNoCurrent