FDA.reportPublic FDA data

NDC 17478-609-01 - ZIOPTAN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17478-609
Requested NDC
17478-609-01
Package NDCs from labels
17478-609-01, 17478-609-90, 17478-609-30, 17478-609-10
Manufacturer
Akorn
Effective date
2022-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZIOPTAN - AkornAkorn2022-10-04HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 25 · 485 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERINRising Pharma Holdings, Inc.db539b39-9504-44d2-9bd5-ba6ffb4410242025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Glycerin ChildrenGLYCERINRising Pharma Holdings, Inc.80a5a944-2882-4f8d-a955-ef827cead5f02025-09-08WarningsExact identifier
unii: PDC6A3C0OX
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
unii: PDC6A3C0OX
Refresh RELIEVA PFCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.d5d3df4a-a311-4f2d-9a24-edfec1a6c9f92025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Refresh OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
unii: PDC6A3C0OX
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
unii: PDC6A3C0OX
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
unii: PDC6A3C0OX
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.