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 1 of 15 · 295 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions64561dfd-3704-4820-aef6-d0d26cef72552026-09-02Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide Hydrochloride and Timolol Maleate Preservative FreeDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEAurobindo Pharma Limitedf41a9cd5-48c8-42eb-bb1b-d0355d9812012026-08-13Warnings, Adverse reactionsExact identifier
rxcui: 1922783
unii: QZO5366EW7
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEAurobindo Pharma Limited2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e12026-08-13Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Timoptic in OcudoseTIMOLOL MALEATENordic Pharma, Inc.16323b0e-78ae-40e5-be93-04f698dd672b2026-08-06Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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: 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
Dorzolamide HClDORZOLAMIDE HCLBausch & Lomb Incorporated8417d162-65a1-4266-bca7-707af1193bf32026-06-29Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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