FDA.reportPublic FDA data

Tafluprost

Product NDC
50742-339
11-digit product format
507420339
Labeler code
50742
Product ID
50742-339_9ebbfaa4-b3c0-46d2-bc83-9817b2d238df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tafluprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA218002
Marketing category
ANDA
Marketing start
2024-12-18
Substance
TAFLUPROST
Active strength
.015 mg/mL
Pharmacologic classes
Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAFLUPROST.015 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1O6WQ6T7G3
Rxcui1244611

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
470fcae6-c316-0386-e573-8b9b4af2f6cdProduct name420250129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-339-05Tafluprost0.3 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.37
50742-339-05Tafluprost5 in 1 POUCHSOLUTION/ DROPS57
50742-339-30Tafluprost6 in 1 CARTONSOLUTION/ DROPS67

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-339-05EA - Each50742-339110db1ab-dba4-49e4-92a0-0bb945253bdb12025-03-04
50742-339-30EA - Each50742-339d377866c-3eea-42ea-a882-8f966ef93c7912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-339TAFLUPROST SOLUTION/ DROPS [INGENUS PHARMACEUTICALS, LLC]7Current NDC, 3 package rows20241219_5d766054-d13f-462c-bf8a-6462e56ca097.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244611tafluprost 0.0015 % Ophthalmic SolutionPSN5d766054-d13f-462c-bf8a-6462e56ca0977
1244611tafluprost 0.015 MG/ML Ophthalmic SolutionSCD5d766054-d13f-462c-bf8a-6462e56ca0977
1244611tafluprost 0.0015 % Ophthalmic SolutionSY5d766054-d13f-462c-bf8a-6462e56ca0977

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-339-05507420339050.3 mL in 1 VIAL, SINGLE-DOSE0.3 mlHistorical
50742-339-30507420339306 POUCH in 1 CARTON (50742-339-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-339-05) / .3 mL in 1 VIAL, SINGLE-DOSE6 pouch2024-12-18NoNoCurrent