Trifluridine

Product NDC
61314-044
11-digit product format
613140044
Labeler code
61314
Product ID
61314-044_d0e32882-06fe-4062-adae-3751ffc9979f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trifluridine
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA074311
Marketing category
ANDA
Marketing start
2001-05-14
Substance
TRIFLURIDINE
Active strength
10 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trifluridine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIFLURIDINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRMW9V5RW38
Rxcui313477

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
82bda68f-d3c9-49d3-a384-e1000d66c66aProduct name320251027
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
c8e66ec4-4652-80f4-9dd2-9c5b0473269cProduct name220170824
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-044-75Trifluridine1 in 1 CARTONSOLUTION16
61314-044-75Trifluridine7.5 mL in 1 BOTTLE, PLASTICSOLUTION7.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-044-75ML - Milliliter61314-044db938f38-19d5-433c-a7f6-32841361b17812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIFLURIDINEACTIVE INGREDIENTRMW9V5RW38TRIFLURIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
TRIFLURIDINEACTIVE MOIETYRMW9V5RW38TRIFLURIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PTRIFLURIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BTRIFLURIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTRIFLURIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
THIMEROSALINACTIVE INGREDIENT2225PI3MOVTRIFLURIDINE SOLUTION [FALCON PHARMACEUTICALS, LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-044TRIFLURIDINE SOLUTION [SANDOZ INC]6Current NDC, Legacy NDC, 2 package rows20241022_abc1d07f-91ee-4421-bc9b-457d0ed41f4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313477trifluridine 1 % Ophthalmic SolutionPSNabc1d07f-91ee-4421-bc9b-457d0ed41f4c6
313477trifluridine 10 MG/ML Ophthalmic SolutionSCDabc1d07f-91ee-4421-bc9b-457d0ed41f4c6
313477trifluridine 1 % Ophthalmic SolutionSYabc1d07f-91ee-4421-bc9b-457d0ed41f4c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61314-044-75613140044751 BOTTLE, PLASTIC in 1 CARTON (61314-044-75) / 7.5 mL in 1 BOTTLE, PLASTIC2001-05-140000-00-00NoNoCurrent