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
Label	Manufacturer	Effective date	Type
Dorzolamide and Timolol - FDC Limited	FDC Limited	2019-11-15	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55545-1007-1	Dorzolamide and Timolol	1 in 1 CARTON	SOLUTION	1	1
55545-1007-1	Dorzolamide and Timolol	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5	1
55545-1007-2	Dorzolamide and Timolol	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10	1
55545-1007-2	Dorzolamide and Timolol	1 in 1 CARTON	SOLUTION	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55545-1007	DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [FDC LIMITED]	1	Legacy NDC, 4 package rows	20191116_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 · 1,430 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rehydrate	AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN	ParaDocs All Natural, Inc.	648fab10-c46b-420f-a42c-6642009d83fb	2023-01-10	Warnings	Exact identifier unii: 059QF0KO0R
Zylast Antiseptic K	BENZALKONIUM CHLORIDE	Innovative Biodefense	84766b3b-915c-b604-e053-2a91aa0a672c	2023-01-01	Warnings	Exact identifier unii: F5UM2KM3W7
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	Sandoz Inc	29157995-fa61-4425-86a5-5bd0e4718cd8	2022-12-20	Warnings, Adverse reactions	Exact identifier unii: QZO5366EW7
Sterile Water	WATER	Fresenius Kabi USA, LLC	b45e9f1d-9c48-4b46-8541-d846b89540df	2022-10-26	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier unii: 059QF0KO0R
Bach Original Flower Remedies Rock Water	WATER	Nelson Bach USA Limited	ea242559-1618-3354-e053-2a95a90a1a95	2022-10-03	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Medical Purchasing Solutions, LLC	e90b47e3-9636-b9ee-e053-2a95a90ad48c	2022-09-19	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
CVS Pharmacy	BENZALKONIUM CHLORIDE	CVS Pharmacy Inc	e78ad7c1-23ab-6fec-e053-2995a90a16c0	2022-08-15	Warnings	Exact identifier unii: F5UM2KM3W7
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Addiclenz	BETA 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 OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: F5UM2KM3W7 unii: 1Q73Q2JULR
Timoptic	TIMOLOL MALEATE	Bausch & Lomb Incorporated	45ac65b3-19f7-4f33-aebf-cadd3daa4bf1	2022-04-30	Warnings, Adverse reactions	Exact identifier unii: P8Y54F701R
Timoptic-XE	TIMOLOL MALEATE	Bausch & Lomb Incorporated	a4d03de7-06b7-4cfc-9d1b-616969df209c	2022-03-31	Warnings, Adverse reactions	Exact identifier unii: P8Y54F701R
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: 1Q73Q2JULR
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Timoptic in Ocudose	TIMOLOL MALEATE	Bausch & Lomb Incorporated	d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf	2022-01-31	Warnings, Adverse reactions	Exact identifier unii: P8Y54F701R
HydrAphex	HYDRAPHEX	Aphex Biocleanse Systems, Inc	a6035c7d-0f5b-3295-e053-2995a90af89c	2022-01-17	Warnings	Exact identifier unii: F5UM2KM3W7
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact 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-c4f95f192ce7	2021-08-12	Warnings, Adverse reactions	Exact identifier unii: P8Y54F701R
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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