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 12 of 25 · 491 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
unii: PDC6A3C0OX
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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