FDA.reportPublic FDA data

Dorzolamide Hydrochloride and Timolol Maleate

Product NDC
61314-030
11-digit product format
613140030
Labeler code
61314
Product ID
61314-030_81902bf8-eb10-4ce2-8d1e-b32ba04adf6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA090604
Marketing category
ANDA
Marketing start
2010-01-02
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
Dorzolamide Hydrochloride and Timolol Maleate
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
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
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-030-01Dorzolamide Hydrochloride and Timolol Maleate5 mL in 1 BOTTLESOLUTION511
61314-030-02Dorzolamide Hydrochloride and Timolol Maleate10 mL in 1 BOTTLESOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-030-02ML - Milliliter61314-0302726c4e0-bd16-4efe-b1f2-281c445a2bc112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
TIMOLOL MALEATEACTIVE INGREDIENTP8Y54F701RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
TIMOLOLACTIVE MOIETY817W3C6175DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
Hydroxyethyl Cellulose (2000 Mpa.s At 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [SANDOZ INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-030DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION [SANDOZ INC]10Current NDC, Legacy NDC, 2 package rows20220218_78f39126-3e3b-4633-a4e0-c1f09a794eec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923432dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic SolutionPSNbe8b1a47-3342-4072-b67c-6d1374d5d4d6100
1923432dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDbe8b1a47-3342-4072-b67c-6d1374d5d4d6100
1923432dorzolamide 2 % / timolol 0.5 % Ophthalmic SolutionSYbe8b1a47-3342-4072-b67c-6d1374d5d4d6100
1923432dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic SolutionSYbe8b1a47-3342-4072-b67c-6d1374d5d4d6100
1923432dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic SolutionPSN78f39126-3e3b-4633-a4e0-c1f09a794eec11
1923432dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCD78f39126-3e3b-4633-a4e0-c1f09a794eec11
1923432dorzolamide 2 % / timolol 0.5 % Ophthalmic SolutionSY78f39126-3e3b-4633-a4e0-c1f09a794eec11
1923432dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic SolutionSY78f39126-3e3b-4633-a4e0-c1f09a794eec11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-030-01613140030015 mL in 1 BOTTLE (61314-030-01) 5 ml2010-01-020000-00-00NoNoCurrent
61314-030-026131400300210 mL in 1 BOTTLE (61314-030-02) 10 ml2010-01-020000-00-00NoNoCurrent