FDA.reportPublic FDA data

COSOPT

Product NDC
17478-605
11-digit product format
174780605
Labeler code
17478
Product ID
17478-605_f8a5f050-49f1-4d22-b376-1d9f96652366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
NDA020869
Marketing category
NDA
Marketing start
2014-04-30
Marketing end
0000-00-00
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
973dd458-49b1-1bb1-62c6-b37c4b15fe1fProduct name520251121
73103a56-9f57-4f32-a306-a42bfa2fea36Product name120250505
425025fc-f910-4afe-815b-58d4486ed4f7Product name420250331
26c5ddae-5c69-622d-e599-5fd583634968Product name420250313
ee780602-134c-4c60-a2f0-e973ba549cd4Product name220250304
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
273981e4-09e7-45cc-967c-554f628ededfProduct name320230627
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-605-102024-01-30C16284748780-1c7ccaba7-1905-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use COSOPT safely and effectively. See full prescribing information for COSOPT. COSOPT ® (dorzolamide hydrochloride and timolol maleate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1998
17478-605-102021-08-10C16284748780-1c7ccaba7-1905-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use COSOPT safely and effectively. See full prescribing information for COSOPT. COSOPT ® (dorzolamide hydrochloride and timolol maleate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1998
17478-605-102021-07-23C16284748780-1c7ccaba7-1905-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use COSOPT safely and effectively. See full prescribing information for COSOPT. COSOPT ® (dorzolamide hydrochloride and timolol maleate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-605-10COSOPT10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS109
17478-605-10COSOPT1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-605-10ML - Milliliter17478-6059d99cd33-016f-4d31-a314-666a0c95b37e12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dorzolamide HydrochlorideACTIVE INGREDIENTQZO5366EW7COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
Timolol MaleateACTIVE INGREDIENTP8Y54F701RCOSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
DorzolamideACTIVE MOIETY9JDX055TW1COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
Timolol AnhydrousACTIVE MOIETY5JKY92S7BRCOSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
Hydroxyethyl Cellulose (2000 MPA.S at 1%)INACTIVE INGREDIENTS38J6RZN16COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
MannitolINACTIVE INGREDIENT3OWL53L36ACOSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCOSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICOSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2
WaterINACTIVE INGREDIENT059QF0KO0RCOSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-605COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]9Legacy NDC, 2 package rows20221203_b7aa1986-1c24-4733-96b3-e6d8e1d44558.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923433COSOPT 2 % / 0.5 % Ophthalmic SolutionPSNb7aa1986-1c24-4733-96b3-e6d8e1d445589
1923432dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic SolutionPSNb7aa1986-1c24-4733-96b3-e6d8e1d445589
1923433dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution [Cosopt]SBDb7aa1986-1c24-4733-96b3-e6d8e1d445589
1923432dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDb7aa1986-1c24-4733-96b3-e6d8e1d445589
1923433Cosopt (dorzolamide 20 MG / timolol 5 MG) per ML Ophthalmic SolutionSYb7aa1986-1c24-4733-96b3-e6d8e1d445589
1923433Cosopt 2 % / 0.5 % Ophthalmic SolutionSYb7aa1986-1c24-4733-96b3-e6d8e1d445589
1923432dorzolamide 2 % / timolol 0.5 % Ophthalmic SolutionSYb7aa1986-1c24-4733-96b3-e6d8e1d445589
1923432dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic SolutionSYb7aa1986-1c24-4733-96b3-e6d8e1d445589

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-605-10174780605101 BOTTLE, DROPPER in 1 CARTON (17478-605-10) > 10 mL in 1 BOTTLE, DROPPER2014-04-300000-00-00NoNoCurrent