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 1 of 16 · 302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TIMOLOL MALEATETIMOLOL MALEATEA-S Medication Solutions64561dfd-3704-4820-aef6-d0d26cef72552026-09-02Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
CVS Health Nausea ReliefSODIUM CITRATE DIHYDRATECVS PHARMACY,INC.a5f9de6f-70d8-4bb0-8a5b-3dd120df29902026-08-14WarningsExact identifier
unii: B22547B95K
Dorzolamide Hydrochloride and Timolol Maleate Preservative FreeDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREEAurobindo Pharma Limitedf41a9cd5-48c8-42eb-bb1b-d0355d9812012026-08-13Warnings, Adverse reactionsExact identifier
application number: ANDA207630
ndc (package): 65862-947-60
ndc (package): 65862-947-15
ndc (package): 65862-947-18
ndc (product): 65862-947
ndc11 (package): 65862094715
rxcui: 1922783
spl id: b02840eb-1403-4b25-b7a9-4484edfa0a50
spl set id: f41a9cd5-48c8-42eb-bb1b-d0355d981201
unii: QZO5366EW7
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEAurobindo Pharma Limited2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e12026-08-13Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Timoptic in OcudoseTIMOLOL MALEATENordic Pharma, Inc.16323b0e-78ae-40e5-be93-04f698dd672b2026-08-06Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dorzolamide HClDORZOLAMIDE HCLBausch & Lomb Incorporated8417d162-65a1-4266-bca7-707af1193bf32026-06-29Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7

Reported adverse events (FAERS/openFDA)#

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