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
Label	Manufacturer	Effective date	Type
ZIOPTAN - Akorn	Akorn	2022-10-04	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-609-10	2024-01-30	C162847	48780-1	1030e365-287f-111a-e063-dadaa90a10e2	These 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
17478-609-30	2024-01-30	C162847	48780-1	1030e365-287f-111a-e063-dadaa90a10e2	These 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
17478-609-90	2024-01-30	C162847	48780-1	1030e365-287f-111a-e063-dadaa90a10e2	These 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 NDC	Product	Description	Form	Quantity	SPL version
17478-609-01	ZIOPTAN	10 in 1 POUCH	SOLUTION/ DROPS	10	10
17478-609-01	ZIOPTAN	0.3 mL in 1 VIAL, SINGLE-USE	SOLUTION/ DROPS	0.3	10
17478-609-10	ZIOPTAN	1 in 1 CARTON	SOLUTION/ DROPS	1	10
17478-609-30	ZIOPTAN	3 in 1 CARTON	SOLUTION/ DROPS	3	10
17478-609-90	ZIOPTAN	9 in 1 CARTON	SOLUTION/ DROPS	9	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-609	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN]	10	Legacy NDC, 5 package rows	20221005_a3173c26-0e19-47af-a01c-3fc06b2700d1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-609-01	EA - Each	17478-609	08d454dd-4bac-4f88-ae52-b1535c54ce1f	1	2015-07-20
17478-609-30	EA - Each	17478-609	90cf9725-5826-47c8-91f9-0d75126df853	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tafluprost	ACTIVE INGREDIENT	1O6WQ6T7G3	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Tafluprost	ACTIVE MOIETY	1O6WQ6T7G3	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Sodium Phosphate, Monobasic, Dihydrate	INACTIVE INGREDIENT	5QWK665956	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	ZIOPTAN (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 19 of 25 · 485 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier unii: PDC6A3C0OX
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier unii: 059QF0KO0R
Oral Health	ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,	Deseret Biologicals, Inc.	6f66ff40-6e0e-4a35-963c-965c65df76eb	2024-04-01	Warnings	Exact identifier unii: QTT17582CB
ULINE Eyewash	EYEWASH	Uline.	14545fc9-1fb4-befa-e063-6294a90a0474	2024-03-23	Warnings	Exact identifier unii: 059QF0KO0R
Habit	CHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUS	Deseret Biologicals, Inc.	3d00a305-e15d-4419-97bd-332421d4a1b0	2024-03-15	Warnings	Exact identifier unii: QTT17582CB
Oral Health	BORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANS	Deseret Biologicals, Inc.	81ffb30f-5255-4e16-ba9d-b0de909aa557	2024-03-05	Warnings	Exact identifier unii: QTT17582CB
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	699310e8-1a93-40b4-a8f4-a765be4a0cb1	2024-02-29	Warnings	Exact identifier unii: PDC6A3C0OX
EPST PLUS	CARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLA	Deseret Biologicals, Inc.	c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc25	2024-02-27	Warnings	Exact identifier unii: QTT17582CB
GI Drainage	CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS	Deseret Biologicals, Inc.	ff81e3ca-2f88-4daf-a734-083107269d3a	2024-02-21	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	Chartwell RX, LLC	3681eeaa-807a-47ca-9fbc-61c2b682800a	2024-02-01		Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	A-S Medication Solutions	dba87371-31d2-47c2-ab83-89aabce4b184	2024-01-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
No More Products	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc	102e7dbb-06dc-f4d1-e063-6394a90aa3eb	2024-01-26	Warnings	Exact identifier unii: PDC6A3C0OX
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc.	0fe10710-ac59-4fc5-e063-6294a90a48fc	2024-01-26	Warnings	Exact identifier unii: PDC6A3C0OX
GENTEAL TEARS	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	A-S Medication Solutions	a2b715e9-332d-4f0b-b8e5-ebc000681586	2024-01-21	Warnings	Exact identifier unii: PDC6A3C0OX
Hydro Gel	GLYCERIN 20%	Trifecta Pharmaceuticals USA LLC	02e8e5d0-7844-39fe-e063-6394a90a57e1	2024-01-19	Warnings	Exact identifier unii: PDC6A3C0OX
B05 GLUCO BALANCE	ADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUM	Apex Energetics Inc.	bae9ff7e-eb69-c61d-e053-2995a90a2627	2024-01-08	Warnings	Exact identifier unii: PDC6A3C0OX
F02 ANGR-FLX	ADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLE	Apex Energetics Inc.	bc7c2bf3-8b0d-766f-e053-2a95a90ad34c	2024-01-08	Warnings	Exact identifier unii: 059QF0KO0R
F09 LTGO	ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS	Apex Energetics Inc.	bd1e652f-b3a4-c5bd-e053-2995a90ae03f	2024-01-08	Warnings	Exact identifier unii: 059QF0KO0R
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	b56ef662-fec2-4d94-e053-2995a90aba2b	2024-01-06	Warnings	Exact identifier unii: 059QF0KO0R
Exchange Select Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Army and Air Force Exchange Service	318bc025-c936-a066-e063-6294a90a4712	2024-01-01	Warnings	Exact identifier unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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