FDA.reportPublic FDA data

Dorzolamide Hydrochloride and Timolol Maleate

Product NDC
50383-261
11-digit product format
503830261
Labeler code
50383
Product ID
50383-261_5c6a634a-b5ed-417d-b4b9-bc389538f59d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
NDA202667
Marketing category
NDA
Marketing start
2019-02-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dorzolamide Hydrochloride and Timolol Maleate
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQZO5366EW7, P8Y54F701R
Rxcui1922783

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-261-61Dorzolamide Hydrochloride and Timolol Maleate4 in 1 CARTONSOLUTION/ DROPS45
50383-261-61Dorzolamide Hydrochloride and Timolol Maleate15 in 1 POUCHSOLUTION/ DROPS155
50383-261-91Dorzolamide Hydrochloride and Timolol Maleate15 in 1 POUCHSOLUTION/ DROPS155
50383-261-91Dorzolamide Hydrochloride and Timolol Maleate12 in 1 CARTONSOLUTION/ DROPS125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-261-61EA - Each50383-261515c0dae-c160-412c-a219-473443536c4612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-261DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [AKORN]4Current NDC, Legacy NDC, 4 package rows20220528_4e90c721-21e8-46ea-ab49-19f535bf7202.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionPSN4e90c721-21e8-46ea-ab49-19f535bf72025
1922783Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCD4e90c721-21e8-46ea-ab49-19f535bf72025
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionSY4e90c721-21e8-46ea-ab49-19f535bf72025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-261-61503830261614 POUCH in 1 CARTON (50383-261-61) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE4 pouch2019-02-010000-00-00NoNoCurrent
50383-261-915038302619112 POUCH in 1 CARTON (50383-261-91) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE12 pouch2019-02-010000-00-00NoNoCurrent