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 2 of 25 · 491 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX
MINICA-SGLYCERINSato Pharmaceutical Co., Ltd.687902eb-e702-4e87-a0ce-9add05e3cbc12026-06-16WarningsExact identifier
unii: PDC6A3C0OX
WALGREEN GLYCERIN ADULTGLYCERIN SUPPOSITORYWalgreens20c44346-0b29-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
WALGREENS GLYCERINGLYCERIN SUSPENSIONWalgreens20c44346-0b2b-7364-e063-6294a90a648f2026-06-15WarningsExact identifier
unii: PDC6A3C0OX
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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