FDA.reportPublic FDA data

NDC 82584-604-01 - COSOPT PF

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
82584-604
Requested NDC
82584-604-01
Package NDCs from labels
82584-604-01, 82584-604-30
Manufacturer
Thea Pharma Inc.
Effective date
2026-05-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COSOPT PF - Thea Pharma Inc.Thea Pharma Inc.2026-05-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82584-604-01COSOPT PF0.2 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.25
82584-604-01COSOPT PF15 in 1 POUCHSOLUTION/ DROPS155
82584-604-30COSOPT PF4 in 1 CARTONSOLUTION/ DROPS45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-604COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [THEA PHARMA INC.]4Current NDC, Legacy NDC, 3 package rows20240110_535fc801-8c3f-4974-a120-3eff1d5a5062.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82584-604-01EA - Each82584-6041022a67e-181f-42ea-998c-9d41a6c06e8312023-03-13
82584-604-30EA - Each82584-60496b6f821-1bdf-4dde-9814-b7b57e23220012023-01-09

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 14 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Timolol Maleate Ophthalmic Gel Forming SolutionTIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTIONFOSUN PHARMA USA INCe93036c6-3120-e989-e053-2a95a90acf7f2023-02-17Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
timolol maleate ophthalmic gel forming solutionTIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTIONGland Pharma Limited79730e4f-d533-42c7-b7b6-cdbc47242baa2023-02-15Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDESandoz Inc29157995-fa61-4425-86a5-5bd0e4718cd82022-12-20Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 1Q73Q2JULR
TimopticTIMOLOL MALEATEBausch & Lomb Incorporated45ac65b3-19f7-4f33-aebf-cadd3daa4bf12022-04-30Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timoptic-XETIMOLOL MALEATEBausch & Lomb Incorporateda4d03de7-06b7-4cfc-9d1b-616969df209c2022-03-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Timoptic in OcudoseTIMOLOL MALEATEBausch & Lomb Incorporatedd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2022-01-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Timolol Maleate Ophthalmic Gel Forming Solution 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25%Dr. Reddy's Laboratories, Inc.d987fdfa-3643-aa1d-cacd-c4f95f192ce72021-08-12Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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