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 16 of 25 · 485 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
unii: PDC6A3C0OX
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
unii: PDC6A3C0OX
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
unii: PDC6A3C0OX
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
unii: PDC6A3C0OX
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: PDC6A3C0OX
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
unii: PDC6A3C0OX
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
TafluprostTAFLUPROSTIngenus Pharmaceuticals, LLC5d766054-d13f-462c-bf8a-6462e56ca0972024-12-04Warnings, Adverse reactionsExact identifier
rxcui: 1244611
unii: 1O6WQ6T7G3
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
unii: PDC6A3C0OX
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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