Ofloxacin

Product NDC: 68788-8993
Requested package NDC: 68788-8993-5
11-digit product format: 687888993
Labeler code: 68788
Product ID: 68788-8993_13222bcc-2b0c-46bb-91a6-574c95221cee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA078559
Marketing category: ANDA
Marketing start: 2016-02-15
Marketing end: 0000-00-00
Substance: OFLOXACIN
Active strength: 3 mg/mL
Pharmacologic classes: Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-8993	68788-8993-5	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078559-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2009-02-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078559-001	AT

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	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078559-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	2009-02-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078559-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078559-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078559-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078559-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078559-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078559-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078559-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078559-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078559-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078559-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078559-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078559-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078559-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078559-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078559-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078559-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078559-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078559-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078559-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078559-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078559-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078559-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078559-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078559-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078559-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078559-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078559-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078559-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078559-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078559-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078559-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078559-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078559-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078559-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078559-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078559-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078559-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078559-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078559-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078559-001	AT	1	`cb3db0bc1861…`

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ofloxacin	OFLOXACIN	ST. MARY'S MEDICAL PARK PHARMACY	27c247e5-ef93-e9a5-e063-6394a90a2e1e	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559
Ofloxacin	OFLOXACIN	A-S Medication Solutions	537c6351-c7f1-47c9-95de-011bac850768	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559
Ofloxacin	OFLOXACIN	Rising Pharma Holdings, Inc.	c76d8dc7-9a66-471b-814b-ef7f3605ec93	2025-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559
Ofloxacin	OFLOXACIN	Proficient Rx LP	a2089612-de4b-4d78-b311-fa2524bd37f6	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078559 application number: ANDA078559

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8993-5	68788899305	5 mL in 1 BOTTLE, PLASTIC (68788-8993-5)	5 ml	2016-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Ophthalmic solution USP 0.3%	Preferred Pharmaceuticals Inc.	2020-08-07	HUMAN PRESCRIPTION DRUG LABEL	5