FDA.reportPublic FDA data

tafluprost

Product NDC
42571-264
11-digit product format
425710264
Labeler code
42571
Product ID
42571-264_4c55f162-175b-d458-e063-6394a90a066f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tafluprost opthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Micro Labs Limited
Application
ANDA209051
Marketing category
ANDA
Marketing start
2022-11-18
Substance
TAFLUPROST
Active strength
.0045 mg/.3mL
Pharmacologic classes
Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAFLUPROST.0045 mg/.3mL

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
42571-264-26tafluprost15 in 1 POUCHSOLUTION/ DROPS156
42571-264-26tafluprost1 in 1 CARTONSOLUTION/ DROPS16
42571-264-73tafluprost2 in 1 CARTONSOLUTION/ DROPS26
42571-264-73tafluprost15 in 1 POUCHSOLUTION/ DROPS156
42571-264-74tafluprost15 in 1 POUCHSOLUTION/ DROPS156
42571-264-74tafluprost6 in 1 CARTONSOLUTION/ DROPS66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-264TAFLUPROST (TAFLUPROST OPTHALMIC) SOLUTION/ DROPS [MICRO LABS LIMITED]5Current NDC, Legacy NDC, 6 package rows20250112_fcaab8b3-3791-49ba-909e-a09651a30b33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244611tafluprost 0.0015 % Ophthalmic SolutionPSNfcaab8b3-3791-49ba-909e-a09651a30b336
1244611tafluprost 0.015 MG/ML Ophthalmic SolutionSCDfcaab8b3-3791-49ba-909e-a09651a30b336
1244611tafluprost 0.0015 % Ophthalmic SolutionSYfcaab8b3-3791-49ba-909e-a09651a30b336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-264-26425710264261 POUCH in 1 CARTON (42571-264-26) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL1 pouch2022-11-180000-00-00NoNoCurrent
42571-264-73425710264732 POUCH in 1 CARTON (42571-264-73) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL2 pouch2022-11-180000-00-00NoNoCurrent
42571-264-74425710264746 POUCH in 1 CARTON (42571-264-74) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL6 pouch2022-11-180000-00-00NoNoCurrent