FDA.reportPublic FDA data

Tafluprost

Product NDC
0781-6184
11-digit product format
007816184
Labeler code
0781
Product ID
0781-6184_d105b545-530d-4a71-8e5a-903ab352c373
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tafluprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA209040
Marketing category
ANDA
Marketing start
2022-12-05
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
0781-6184-14Tafluprost0.3 mL in 1 CONTAINERSOLUTION/ DROPS0.312
0781-6184-14Tafluprost5 in 1 POUCHSOLUTION/ DROPS512
0781-6184-87Tafluprost6 in 1 CARTONSOLUTION/ DROPS612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6184-14EA - Each0781-61848b3f3c7e-e485-42aa-b496-34a61ec0f3cc12023-01-09
0781-6184-87EA - Each0781-6184543a54f6-1383-4f6e-b53e-caaf7bfc4c2912023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6184TAFLUPROST SOLUTION/ DROPS [SANDOZ INC]11Current NDC, Legacy NDC, 3 package rows20221205_bfffa484-4105-45ec-ab1d-124e96639f35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244611tafluprost 0.0015 % Ophthalmic SolutionPSNbfffa484-4105-45ec-ab1d-124e96639f3512
1244611tafluprost 0.015 MG/ML Ophthalmic SolutionSCDbfffa484-4105-45ec-ab1d-124e96639f3512
1244611tafluprost 0.0015 % Ophthalmic SolutionSYbfffa484-4105-45ec-ab1d-124e96639f3512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6184-14007816184140.3 mL in 1 CONTAINER0.3 mlHistorical
0781-6184-87007816184876 POUCH in 1 CARTON (0781-6184-87) / 5 CONTAINER in 1 POUCH (0781-6184-14) / .3 mL in 1 CONTAINER6 pouch2022-12-050000-00-00NoNoCurrent