FDA.reportPublic FDA data

ZIOPTAN

Product NDC
17478-609
11-digit product format
174780609
Labeler code
17478
Product ID
17478-609_d9181c54-4a33-414c-9f2c-6a372532fb22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tafluprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
NDA202514
Marketing category
NDA
Marketing start
2014-11-26
Marketing end
0000-00-00
Substance
TAFLUPROST
Active strength
0 mg/.3mL
Pharmacologic classes
Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-609-102024-01-30C16284748780-11030e365-287f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN ® . ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012
17478-609-302024-01-30C16284748780-11030e365-287f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN ® . ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012
17478-609-902024-01-30C16284748780-11030e365-287f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN ® . ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-609-01ZIOPTAN10 in 1 POUCHSOLUTION/ DROPS1010
17478-609-01ZIOPTAN0.3 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.310
17478-609-10ZIOPTAN1 in 1 CARTONSOLUTION/ DROPS110
17478-609-30ZIOPTAN3 in 1 CARTONSOLUTION/ DROPS310
17478-609-90ZIOPTAN9 in 1 CARTONSOLUTION/ DROPS910

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-609-01EA - Each17478-60908d454dd-4bac-4f88-ae52-b1535c54ce1f12015-07-20
17478-609-30EA - Each17478-60990cf9725-5826-47c8-91f9-0d75126df85312015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TafluprostACTIVE INGREDIENT1O6WQ6T7G3ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
TafluprostACTIVE MOIETY1O6WQ6T7G3ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
Sodium Phosphate, Monobasic, DihydrateINACTIVE INGREDIENT5QWK665956ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-609ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN]10Legacy NDC, 5 package rows20221005_a3173c26-0e19-47af-a01c-3fc06b2700d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244611tafluprost 0.0015 % Ophthalmic SolutionPSNa3173c26-0e19-47af-a01c-3fc06b2700d110
1244616ZIOPTAN 0.0015 % Ophthalmic SolutionPSNa3173c26-0e19-47af-a01c-3fc06b2700d110
1244616tafluprost 0.015 MG/ML Ophthalmic Solution [Zioptan]SBDa3173c26-0e19-47af-a01c-3fc06b2700d110
1244611tafluprost 0.015 MG/ML Ophthalmic SolutionSCDa3173c26-0e19-47af-a01c-3fc06b2700d110
1244611tafluprost 0.0015 % Ophthalmic SolutionSYa3173c26-0e19-47af-a01c-3fc06b2700d110
1244616Zioptan 0.0015 % Ophthalmic SolutionSYa3173c26-0e19-47af-a01c-3fc06b2700d110
1244616Zioptan 0.0045 MG in 0.3 ML Ophthalmic SolutionSYa3173c26-0e19-47af-a01c-3fc06b2700d110
1244616Zioptan 0.015 MG/ML Ophthalmic SolutionSYa3173c26-0e19-47af-a01c-3fc06b2700d110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-609-011747806090110 in 1 POUCHHistorical
17478-609-10174780609101 POUCH in 1 CARTON (17478-609-10) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .3 mL in 1 VIAL, SINGLE-USE1 pouch2017-11-260000-00-00NoNoCurrent
17478-609-30174780609303 POUCH in 1 CARTON (17478-609-30) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .3 mL in 1 VIAL, SINGLE-USE3 pouch2017-11-260000-00-00NoNoCurrent
17478-609-90174780609909 POUCH in 1 CARTON (17478-609-90) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .3 mL in 1 VIAL, SINGLE-USE9 pouch2017-11-260000-00-00NoNoCurrent