FDA.reportPublic FDA data

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution

Product NDC
46708-553
11-digit product format
467080553
Labeler code
46708
Product ID
46708-553_2b1fa44a-3890-4634-bcfc-c7310b51128e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213099
Marketing category
ANDA
Marketing start
2021-05-04
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 Ophthalmic Solution
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
Rxcui1923432

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
46708-553-10Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution10 mL in 1 BOTTLESOLUTION/ DROPS101
46708-553-10Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-553DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20241107_2b1fa44a-3890-4634-bcfc-c7310b51128e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923432dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic SolutionPSN2b1fa44a-3890-4634-bcfc-c7310b51128e1
1923432dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCD2b1fa44a-3890-4634-bcfc-c7310b51128e1
1923432dorzolamide 2 % / timolol 0.5 % Ophthalmic SolutionSY2b1fa44a-3890-4634-bcfc-c7310b51128e1
1923432dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic SolutionSY2b1fa44a-3890-4634-bcfc-c7310b51128e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-553-10467080553101 BOTTLE in 1 CARTON (46708-553-10) / 10 mL in 1 BOTTLE1 bottle2021-05-04NoNoCurrent