FDA.reportPublic FDA data

Dorzolamide Hydrochloride and Timolol Maleate

Product NDC
50383-233
Requested package NDC
50383-233-10
11-digit product format
503830233
Labeler code
50383
Product ID
50383-233_d893628a-2d64-464a-b948-2abfafdf83c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA077847
Marketing category
ANDA
Marketing start
2008-10-28
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50383-23350383-233-10IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2008-10-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077847-001DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEEQ 2% BASE;EQ 0.5% BASESOLUTION/DROPS / OPHTHALMIC2008-10-28a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-233-052024-01-30C16284748780-11030e365-6253-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution safely and effectively. See full prescribing information for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Initial U.S. Approval: 1998
50383-233-102024-01-30C16284748780-11030e365-6253-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution safely and effectively. See full prescribing information for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-233-05Dorzolamide Hydrochloride and Timolol Maleate1 in 1 BOXSOLUTION/ DROPS114
50383-233-05Dorzolamide Hydrochloride and Timolol Maleate5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS514
50383-233-10Dorzolamide Hydrochloride and Timolol Maleate1 in 1 BOXSOLUTION/ DROPS114
50383-233-10Dorzolamide Hydrochloride and Timolol Maleate10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-233-10ML - Milliliter50383-2332ebbaa0c-5ac2-41a7-bf6a-45a2a8223ed712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
TIMOLOL ANHYDROUSACTIVE MOIETY5JKY92S7BRDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]6
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
TIMOLOLACTIVE MOIETY817W3C6175DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-233DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [AKORN]14Legacy NDC, 4 package rows20220602_2a236f05-1ee1-4180-9d80-31518d2204c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923432dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic SolutionPSN2a236f05-1ee1-4180-9d80-31518d2204c714
1923432dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCD2a236f05-1ee1-4180-9d80-31518d2204c714
1923432dorzolamide 2 % / timolol 0.5 % Ophthalmic SolutionSY2a236f05-1ee1-4180-9d80-31518d2204c714
1923432dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic SolutionSY2a236f05-1ee1-4180-9d80-31518d2204c714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-233-10503830233101 BOTTLE, DROPPER in 1 BOX (50383-233-10) > 10 mL in 1 BOTTLE, DROPPER2009-10-280000-00-00NoNoCurrent