Ofloxacin

Product NDC: 0517-0760
11-digit product format: 005170760
Labeler code: 0517
Product ID: 0517-0760_e4abdf47-d651-478c-be0b-88b2f256023c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: American Regent, Inc.
Application: ANDA076830
Marketing category: ANDA
Marketing start: 2010-07-01
Marketing end: 0000-00-00
Substance: OFLOXACIN
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0517-0760		I	Inactivated by FDA		2026-08-11
excluded package	package	0517-0760	0517-0760-01	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0517-0760-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0517-0760-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0517-0760-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0517-0760-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0517-0760-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0517-0760-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0517-0760-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0517-0760-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0517-0760-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0517-0760-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0517-0760-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0517-0760-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0517-0760-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0517-0760-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0517-0760-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0517-0760-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0517-0760-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0517-0760-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0517-0760-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0517-0760-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0517-0760-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0517-0760-01	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076830-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC			2004-08-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2004-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076830-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC		2004-08-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076830-001	AT	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A076830-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076830-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076830-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076830-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076830-001	AT	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f9d82093-3de1-4841-9a42-67222d61a0cf	Product name	4	20250515
bbed5f06-a6b7-a443-70ac-77518a9524b7	Product name	7	20250311
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
41679fed-052c-574b-6b40-cadcbc315b79	Product name	2	20150401
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0517-0760-01	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
0517-0760-01	Ofloxacin	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5		1
0517-0760-01	Ofloxacin	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-0760-01	ML - Milliliter	0517-0760	c1dba322-89e1-4316-8805-b44aae3d3454	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-0760	OFLOXACIN SOLUTION/ DROPS [AMERICAN REGENT, INC.]	1	Legacy NDC, 2 package rows	20180616_227e11ab-4e07-4e34-b21d-ef965bae6272.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A4P49JAZ9H	OFLOXACIN	82419-36-1	OFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	227e11ab-4e07-4e34-b21d-ef965bae6272	1
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	227e11ab-4e07-4e34-b21d-ef965bae6272	1
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	227e11ab-4e07-4e34-b21d-ef965bae6272	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0517-0760-01	00517076001	5 mL in 1 BOTTLE	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)	American Regent, Inc. \| PharmaForce, Inc.	2010-07-08	HUMAN PRESCRIPTION DRUG LABEL	1