FDA.reportPublic FDA data

NDC 17478-604-01 - 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
17478-604
Requested NDC
17478-604-01
Package NDCs from labels
17478-604-01, 17478-604-90, 17478-604-30, 17478-604-00, 17478-604-15
Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2020-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COSOPT PF - Akorn | Akorn Operating Company LLCAkorn | Akorn Operating Company LLC2020-10-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-604-152024-01-30C16284748780-11030e365-10a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use COSOPT PF safely and effectively. See full prescribing information for COSOPT PF. COSOPT® PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution) 2%/0.5% Initial U.S. Approval: 1998
17478-604-302024-01-30C16284748780-11030e365-10a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use COSOPT PF safely and effectively. See full prescribing information for COSOPT PF. COSOPT® PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution) 2%/0.5% Initial U.S. Approval: 1998
17478-604-902024-01-30C16284748780-11030e365-10a4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use COSOPT PF safely and effectively. See full prescribing information for COSOPT PF. COSOPT® PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution) 2%/0.5% Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-604-00COSOPT PF15 in 1 POUCHSOLUTION/ DROPS156
17478-604-00COSOPT PF0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.26
17478-604-01COSOPT PF15 in 1 POUCHSOLUTION/ DROPS156
17478-604-01COSOPT PF0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.26
17478-604-15COSOPT PF2 in 1 CARTONSOLUTION/ DROPS26
17478-604-30COSOPT PF4 in 1 CARTONSOLUTION/ DROPS46
17478-604-90COSOPT PF12 in 1 CARTONSOLUTION/ DROPS126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-604COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]6Legacy NDC, 7 package rows20220503_a8d4e2b5-c7bb-48fc-9314-7095cd77617e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-604-01EA - Each17478-604376fd337-dfb7-4393-b398-a1bfaeb7466212016-03-04
17478-604-30EA - Each17478-60411a2fdb5-20d9-4501-be22-e70ab63f069112014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dorzolamide HydrochlorideACTIVE INGREDIENTQZO5366EW7COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
Timolol MaleateACTIVE INGREDIENTP8Y54F701RCOSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
DorzolamideACTIVE MOIETY9JDX055TW1COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
Timolol AnhydrousACTIVE MOIETY5JKY92S7BRCOSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
MannitolINACTIVE INGREDIENT3OWL53L36ACOSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCOSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICOSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCOSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.]1

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 3 of 15 · 294 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepackff76c0cf-256c-4015-94f4-405f0c46205f2026-05-01Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEMicro Labs Limitedb0a1d984-efee-4751-9797-c09adc2d307d2026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 1922783
unii: QZO5366EW7
unii: P8Y54F701R
Brimonidine Tartrate/Timolol Maleate Ophthalmic SolutionBRIMONIDINE TARTRATE AND TIMOLOL MALEATEApotex Corp.268c3f6b-8798-7987-3b8c-7b7f560af5d72026-04-23Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate and Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEAlembic Pharmaceuticals Inc.10e79593-b991-4899-89fd-6fff7a213d812026-04-01Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Brimonidine Tartrate and Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATESandoz Incaf21d2e5-0029-4889-ba93-6417baa91ce62026-03-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
COMBIGANBRIMONIDINE TARTRATE, TIMOLOL MALEATEAllergan, Inc.feaf1480-a4b8-4486-992a-96be3a5962432026-03-17Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Timolol MaleateTIMOLOL MALEATESandoz Incf949fa34-6a9a-40d5-91ab-ff1cbb79b9ea2026-02-20Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDESagent Pharmaceuticals0246463c-6c24-4611-8e22-2d5254ace66a2026-01-09Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Timolol MaleateTIMOLOL MALEATESagent Pharmaceuticals272bb565-f099-4896-b2f6-48ab9180e9412026-01-09Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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