NDC 0517-0761 - Ofloxacin

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: 0517-0761
Package NDCs from labels: 0517-0761-01
Manufacturer: American Regent, Inc. | PharmaForce, Inc.
Effective date: 2010-07-08
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)	American Regent, Inc. \| PharmaForce, Inc.	2010-07-08	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0517-0761-01	2019-10-21	C162847	48780-1	956f9ecf-c04e-621f-e053-dbdaa90a74ad	OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0517-0761-01	Ofloxacin	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10		1
0517-0761-01	Ofloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-0761	OFLOXACIN SOLUTION/ DROPS [AMERICAN REGENT, INC.]	1	2 package rows	20180616_227e11ab-4e07-4e34-b21d-ef965bae6272.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 114 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2a96096d-43cc-49b7-af53-b53c17f41001	2014-07-25	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	b3b4b176-41f0-4ca8-90d4-3fba5707564a	2014-02-21		Exact identifier unii: 451W47IQ8X
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21		Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X
e4abdf47-d651-478c-be0b-88b2f256023c			227e11ab-4e07-4e34-b21d-ef965bae6272	2010-07-08	Warnings, Adverse reactions	Exact identifier spl id: e4abdf47-d651-478c-be0b-88b2f256023c spl set id: 227e11ab-4e07-4e34-b21d-ef965bae6272

Reported adverse events (FAERS/openFDA)#

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