FDA.reportPublic FDA data

Dorzolamide HCl and Timolol Maleate

Product NDC
50090-2867
11-digit product format
500902867
Labeler code
50090
Product ID
50090-2867_bf1811bf-ad10-450d-9000-d2e13a092f98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA202054
Marketing category
ANDA
Marketing start
2015-02-17
Marketing end
0000-00-00
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20 mg/mL; mg/mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
50090-2867-02020-01-31C16284748780-19d75b9d0-94b7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION . DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE ophthalmic solution, USP Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2867-0Dorzolamide HCl and Timolol Maleate10 mL in 1 BOTTLE, DISPENSINGSOLUTION103
50090-2867-0Dorzolamide HCl and Timolol Maleate1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2867-0ML - Milliliter50090-2867773ea9d0-e3aa-402e-8676-b94f9aa05a4012019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2867DORZOLAMIDE HCL AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20180215_adf59642-b978-4bce-bdf2-7ee1d12c45a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923432dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic SolutionPSNadf59642-b978-4bce-bdf2-7ee1d12c45a33
1923432dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDadf59642-b978-4bce-bdf2-7ee1d12c45a33
1923432dorzolamide 2 % / timolol 0.5 % Ophthalmic SolutionSYadf59642-b978-4bce-bdf2-7ee1d12c45a33
1923432dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic SolutionSYadf59642-b978-4bce-bdf2-7ee1d12c45a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50090-2867-05009028670010 mL in 1 BOTTLE, DISPENSING10 mlHistorical