FDA.reportPublic FDA data

NDC 65862-947-15 - Dorzolamide Hydrochloride and Timolol Maleate Preservative Free

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
65862-947
Requested NDC
65862-947-15
Package NDCs from labels
65862-947-15, 65862-947-60, 65862-947-18
Manufacturer
Aurobindo Pharma Limited | EUGIA PHARMA SPECIALITIES LIMITED
Effective date
2026-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DORZOLAMIDE - Aurobindo Pharma Limited | EUGIA PHARMA SPECIALITIES LIMITEDAurobindo Pharma Limited | EUGIA PHARMA SPECIALITIES LIMITED2026-08-13Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-947-15Dorzolamide Hydrochloride and Timolol Maleate Preservative Free0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.23
65862-947-15Dorzolamide Hydrochloride and Timolol Maleate Preservative Free15 in 1 POUCHSOLUTION/ DROPS153
65862-947-18Dorzolamide Hydrochloride and Timolol Maleate Preservative Free15 in 1 POUCHSOLUTION/ DROPS153
65862-947-18Dorzolamide Hydrochloride and Timolol Maleate Preservative Free12 in 1 CARTONSOLUTION/ DROPS123
65862-947-60Dorzolamide Hydrochloride and Timolol Maleate Preservative Free4 in 1 CARTONSOLUTION/ DROPS43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-947DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE SOLUTION/ DROPS [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 5 package rows20230823_f41a9cd5-48c8-42eb-bb1b-d0355d981201.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-947-15EA - Each65862-947d3c2fd4a-4d96-4df7-ad3b-c264049d821312018-08-13
65862-947-60EA - Each65862-9479d0f3b10-f1ea-4cb4-89fc-2a69c697658512018-08-13

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 2 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide Hydrochloride OphthalmicDORZOLAMIDE HYDROCHLORIDE OPHTHALMICFlorida Pharmaceutical Products, LLCe4e6a5a8-f7be-4424-83f2-d6bb4d57443e2026-06-24Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate and Timolol maleate Ophthalmic SolutionBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGland Pharma Limited038cf2ba-ad08-4981-a3cc-bff0e4ba5dfb2026-06-16Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: B22547B95K
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepack09dbed18-9076-4891-93a7-d14bb22179262026-06-12Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC02d89d37-cbca-4e06-83ef-2a10f988f1ea2026-06-12Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
BRIMONIDINE TARTRATE AND TIMOLOL MALEATEBRIMONIDINE TARTRATE AND TIMOLOL MALEATEFlorida Pharmaceutical Products, LLC7011a203-46cf-434d-ba11-253f107ff80f2026-05-27Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: B22547B95K
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
COSOPT PFDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEThea Pharma Inc.535fc801-8c3f-4974-a120-3eff1d5a50622026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 1922783
unii: QZO5366EW7
unii: P8Y54F701R
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate/Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEGlenmark Pharmaceuticals Inc., USAbf6a7f59-5a10-49fe-9e57-19e3ba2029182026-05-06Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepackff76c0cf-256c-4015-94f4-405f0c46205f2026-05-01Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R

Reported adverse events (FAERS/openFDA)#

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