FDA.reportPublic FDA data

NDC 42571-382-71 - DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
42571-382
Requested NDC
42571-382-71
Package NDCs from labels
42571-382-71, 42571-382-73, 42571-382-27
Manufacturer
Micro Labs Limited
Effective date
2026-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - Micro Labs LimitedMicro Labs Limited2026-04-30HUMAN PRESCRIPTION DRUG LABEL
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 9 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IstalolTIMOLOL MALEATEBausch & Lomb Incorporated258bbc8d-00ee-45b0-ac35-6f16c4e8d45f2024-10-30Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
TIMOLOL MALEATETIMOLOL MALEATELeading Pharma, LLCd6fa2971-dacf-42ab-99bc-c7ce6013221e2024-10-30Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
timolol maleateTIMOLOL MALEATENorthStar RxLLC9db7322d-eb31-4fff-9b14-8a0294d017042024-10-14Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Brimonidine Tartrate and Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATESomerset Therapeutics, LLCe4fdbd17-73b7-49ed-9de3-591f36e0645d2024-10-14Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: B22547B95K
Dorzolamide HydrochlorideDORZOLAMIDEIndoco Remedies Limited462a61b2-1ec6-4d18-bc6b-fc03e027caa02024-10-04Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Timolol MaleateTIMOLOL MALEATE OPHTHALMICMicro Labs Limited6c9f3971-8c07-4d3a-915d-76438baa2a0b2024-10-03Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: B22547B95K
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEMicro Labs Limitedf45cce05-fb47-4607-b68e-5a3d47e7235a2024-09-26Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: B22547B95K
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATESomerset Therapeutics, LLC17f04726-725f-4839-911d-47fc5e02baae2024-09-18Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Inc.5ad43fd4-19f0-448f-97a8-625ada4cb1472024-08-27Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEAlembic Pharmaceuticals Limitedfb2e0729-b0bc-4c3f-9961-8bb38f84a0322024-08-27Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEBryant Ranch Prepackcfdc5577-fe7a-4b51-b2f5-95806e1dee2d2024-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA215936
ndc (package): 72162-2387-7
ndc (package): 72162-2387-6
ndc (product): 72162-2387
rxcui: 1922783
spl id: 62dcb93d-a693-4995-b77e-c1f74c341afa
spl set id: cfdc5577-fe7a-4b51-b2f5-95806e1dee2d
unii: QZO5366EW7
unii: P8Y54F701R
Timolol MaleateTIMOLOL MALEATECaplin Steriles Limited4847f180-45e6-40f0-ae8c-6cc500cb0add2024-08-19Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.