FDA.reportPublic FDA data

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product NDC
42571-382
11-digit product format
425710382
Labeler code
42571
Product ID
42571-382_50aa565b-e11f-8176-e063-6294a90ab0b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Micro Labs Limited
Application
ANDA215936
Marketing category
ANDA
Marketing start
2022-02-15
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
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
d11e749b-f93e-0ce3-ceda-28fe03d8081dProduct name220190731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-382-27DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE12 in 1 CARTONSOLUTION/ DROPS126
42571-382-27DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE15 in 1 POUCHSOLUTION/ DROPS156
42571-382-71DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.26
42571-382-71DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE15 in 1 POUCHSOLUTION/ DROPS156
42571-382-73DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE4 in 1 CARTONSOLUTION/ DROPS46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-382-71EA - Each42571-3826e6978e1-9957-48ed-9189-ab5ec85a972c12022-04-06
42571-382-73EA - Each42571-3821effc12b-e81b-4521-b3b2-ae21f346ac1912022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-382DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE) SOLUTION/ DROPS [MICRO LABS LIMITED]5Current NDC, Legacy NDC, 5 package rows20241207_b0a1d984-efee-4751-9797-c09adc2d307d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionPSNcfdc5577-fe7a-4b51-b2f5-95806e1dee2d100
1922783Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDcfdc5577-fe7a-4b51-b2f5-95806e1dee2d100
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionSYcfdc5577-fe7a-4b51-b2f5-95806e1dee2d100
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionPSNb0a1d984-efee-4751-9797-c09adc2d307d6
1922783Preservative-Free dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic SolutionSCDb0a1d984-efee-4751-9797-c09adc2d307d6
1922783dorzolamide 2 % / timolol 0.5 % PF Ophthalmic SolutionSYb0a1d984-efee-4751-9797-c09adc2d307d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-382-274257103822712 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE12 pouch2022-03-230000-00-00NoNoCurrent
42571-382-71425710382710.2 mL in 1 VIAL, SINGLE-USE0.2 mlHistorical
42571-382-73425710382734 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE4 pouch2022-03-230000-00-00NoNoCurrent