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 10 of 15 · 291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEMicro Labs Limitedf45cce05-fb47-4607-b68e-5a3d47e7235a2024-09-26Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATESomerset Therapeutics, LLC17f04726-725f-4839-911d-47fc5e02baae2024-09-18Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Inc.5ad43fd4-19f0-448f-97a8-625ada4cb1472024-08-27Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Limitedfb2e0729-b0bc-4c3f-9961-8bb38f84a0322024-08-27Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEBryant Ranch Prepackcfdc5577-fe7a-4b51-b2f5-95806e1dee2d2024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 1922783
unii: QZO5366EW7
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATECaplin Steriles Limited4847f180-45e6-40f0-ae8c-6cc500cb0add2024-08-19Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
Timolol hemihydrateTIMOLOL HEMIHYDRATESomerset Therapeutics, LLCbfd95433-e47a-4c5c-9bdf-77bffc13544d2024-07-10Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timolol maleateTIMOLOL MALEATESomerset Therapeutics, LLC5d60db57-ca24-4cab-a90d-8cf06992a34e2024-07-04Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Timolol MaleateTIMOLOL MALEATERising Pharma Holdings, Inc.0bc40b2c-65eb-4095-87e6-4752d5b19a3a2024-06-11Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions1ffd9ed1-8ab4-4036-bbc6-dcf58e6592482024-06-03Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Timolol GFSTIMOLOL MALEATESandoz Inc72b0d0ec-832a-4c25-b845-2537ab5063542024-05-28Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide and TimololDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTIONLeading Pharma, LLCc9ae08c5-275d-44b3-9d1e-5d8fedc21b962024-05-25Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Dorzolamide hydrochlorideDORZOLAMIDE HYDROCHLORIDELeading Pharma, LLC7d4cb6cd-86d0-41d9-baa9-bca0fa7b06942024-05-24Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7

Reported adverse events (FAERS/openFDA)#

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