NDC 55545-1007-1 - 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
55545-1007-1
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 70 of 72 · 1,423 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PharmacyBENZALKONIUM CHLORIDECVS Pharmacy Ince78ad7c1-23ab-6fec-e053-2995a90a16c02022-08-15WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: F5UM2KM3W7
unii: 1Q73Q2JULR
TimopticTIMOLOL MALEATEBausch & Lomb Incorporated45ac65b3-19f7-4f33-aebf-cadd3daa4bf12022-04-30Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Timoptic-XETIMOLOL MALEATEBausch & Lomb Incorporateda4d03de7-06b7-4cfc-9d1b-616969df209c2022-03-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Timoptic in OcudoseTIMOLOL MALEATEBausch & Lomb Incorporatedd130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf2022-01-31Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
HydrAphexHYDRAPHEXAphex Biocleanse Systems, Inca6035c7d-0f5b-3295-e053-2995a90af89c2022-01-17WarningsExact identifier
unii: F5UM2KM3W7
TreprostinilTREPROSTINILDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Timolol Maleate Ophthalmic Gel Forming Solution 0.25%TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25%Dr. Reddy's Laboratories, Inc.d987fdfa-3643-aa1d-cacd-c4f95f192ce72021-08-12Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
unii: F5UM2KM3W7
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Life is Simple Hand SanitizerNON-ALCOHOL FOAMING HAND SANITIZERApollo Health and Beauty Care0c5fad07-a91a-4d5f-8554-0d2f3a13ab132020-10-06WarningsExact identifier
unii: F5UM2KM3W7
Timolol MaleateTIMOLOL MALEATEMylan Pharmaceuticals Inc.57c62928-63d8-4505-9b9e-c085a3a12c952020-07-06Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R

Reported adverse events (FAERS/openFDA)#

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