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 12 of 15 · 294 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide Hydrochloride OphthalmicDORZOLAMIDE HYDROCHLORIDEA-S Medication Solutionsfa4b8802-3271-48a4-8a91-229ebc72f5702023-12-15Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepackbe8b1a47-3342-4072-b67c-6d1374d5d4d62023-12-07Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate/Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEARMAS PHARMACEUTICALS INC09476aab-0816-812c-e063-6394a90a12a22023-11-03Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATEIngenus Pharmaceuticals, LLC4c4318b3-9865-4172-a7bd-9e68913eca1e2023-10-25Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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