FDA.reportPublic FDA data

NDC 55545-1007-2 - Dorzolamide and Timolol

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
55545-1007
Requested NDC
55545-1007-2
Package NDCs from labels
55545-1007-1, 55545-1007-2
Manufacturer
FDC Limited
Effective date
2019-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dorzolamide and Timolol - FDC LimitedFDC Limited2019-11-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1007-1Dorzolamide and Timolol1 in 1 CARTONSOLUTION11
55545-1007-1Dorzolamide and Timolol5 mL in 1 BOTTLE, PLASTICSOLUTION51
55545-1007-2Dorzolamide and Timolol10 mL in 1 BOTTLE, PLASTICSOLUTION101
55545-1007-2Dorzolamide and Timolol1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1007DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [FDC LIMITED]1Legacy NDC, 4 package rows20191116_3189b866-d8ba-4ffc-a51b-20a46ce9c361.zip

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 69 of 72 · 1,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Brimonidine Tartrate and Timolol MaleateBRIMONIDINE TARTRATE AND TIMOLOL MALEATEAlembic Pharmaceuticals Limitedb5d560b6-847e-4f09-b1ef-22e4deb8a2062023-08-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
Antibacterial Hand CleanserBENZALKONIUM CHLORIDEKutol Products Company56f50eda-5399-1bfe-e054-00144ff8d46c2023-08-28WarningsExact identifier
unii: F5UM2KM3W7
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Dorzolamide hydrochloride and timolol maleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEIngenus Pharmaceuticals, LLC36c0e765-dfda-4b3b-8a98-a5f8b32607f72023-08-02Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Timolol Maleate Ophthalmic Gel Forming Solution 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25%NorthStar RxLLC9515f95c-e29b-3c7f-0bdd-cda783988a722023-07-18Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
timolol maleateTIMOLOL MALEATELifestar Pharma LLC545b7bee-8d5d-4206-b973-8de3c14d6dfe2023-07-03Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Dorzolamide Hydrochloride and Timolol MaleateDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBausch & Lomb Incorporated7f6ab3f6-3644-434c-b6cf-e4f111d189622023-06-23Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TOUCH Sanitizing Germ Block, Unscented, 1oz (28.35g)BENZALKONIUM CHLORIDERelevo, Inc.c3ba1f21-51d9-c4ee-e053-2995a90aa0422023-05-16WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Timolol Maleate Ophthalmic Gel Forming SolutionTIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTIONFOSUN PHARMA USA INCe93036c6-3120-e989-e053-2a95a90acf7f2023-02-17Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
timolol maleate ophthalmic gel forming solutionTIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTIONGland Pharma Limited79730e4f-d533-42c7-b7b6-cdbc47242baa2023-02-15Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R

Reported adverse events (FAERS/openFDA)#

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