FDA.reportPublic FDA data

COSOPT PF

Product NDC
82584-604
11-digit product format
825840604
Labeler code
82584
Product ID
82584-604_51b818ee-6194-a845-e063-6394a90ae44b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dorzolamide hydrochloride and timolol maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Thea Pharma Inc.
Application
NDA202667
Marketing category
NDA
Marketing start
2022-12-10
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20; 5 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COSOPT PF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DORZOLAMIDE HYDROCHLORIDE20 mg/mL
TIMOLOL MALEATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQZO5366EW7, P8Y54F701R
Rxcui1922783, 1922784

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

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922784COSOPT PF 2 % / 0.5 % Ophthalmic SolutionPSN535fc801-8c3f-4974-a120-3eff1d5a50625
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionPSN535fc801-8c3f-4974-a120-3eff1d5a50625
1922784Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution [Cosopt]SBD535fc801-8c3f-4974-a120-3eff1d5a50625
1922783Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCD535fc801-8c3f-4974-a120-3eff1d5a50625
1922784Cosopt PF (dorzolamide 2 % / timolol 0.5 % ) Ophthalmic SolutionSY535fc801-8c3f-4974-a120-3eff1d5a50625
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionSY535fc801-8c3f-4974-a120-3eff1d5a50625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82584-604-01825840604010.2 mL in 1 VIAL, SINGLE-DOSE0.2 mlHistorical
82584-604-30825840604304 POUCH in 1 CARTON (82584-604-30) / 15 VIAL, SINGLE-DOSE in 1 POUCH (82584-604-01) / .2 mL in 1 VIAL, SINGLE-DOSE4 pouch2022-12-100000-00-00NoNoCurrent