Ofloxacin Otic

Product NDC: 68788-9504
11-digit product format: 687889504
Labeler code: 68788
Product ID: 68788-9504_715b4f79-3294-46f5-bc96-22f85dc47da2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ofloxacin
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA076527
Marketing category: ANDA
Marketing start: 2014-02-21
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: 2020-12-31
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	68788-9504		D	Discontinued by firm		2026-08-11
excluded package	package	68788-9504	68788-9504-5	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 · 24 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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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	68788-9504-5	`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
A076527-001	OFLOXACIN	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT		2007-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076527-001	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	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076527-001	OFLOXACIN	0.3%	SOLUTION/DROPS / OTIC	AT	2007-09-28	`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	A076527-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076527-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076527-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076527-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076527-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076527-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076527-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076527-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076527-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076527-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076527-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076527-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076527-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076527-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076527-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076527-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076527-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076527-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076527-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076527-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076527-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076527-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076527-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076527-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076527-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076527-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076527-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076527-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076527-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076527-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076527-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076527-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076527-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076527-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076527-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076527-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076527-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076527-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076527-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076527-001	AT	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OFLOXACIN	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
OFLOXACIN	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFLOXACIN OTIC (OFLOXACIN) SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	1

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OFLOXACIN OTIC	OFLOXACIN	DIRECT RX	a7952956-b64a-0f99-e053-2995a90a0f91	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	7ba2d774-27d8-4ee0-9ef3-cc4900dcc5fa	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	REMEDYREPACK INC.	42366170-e536-46a1-9735-d76e5820a9de	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Apotex Corp.	8db221b1-32f3-f6ca-e404-71f56a860d08	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	76f461da-0e15-aa6d-e053-2a91aa0a9808	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	4f4048b2-3ae8-441a-b1e3-7311fac00f94	2024-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Bryant Ranch Prepack	567fa672-5fd0-4a1d-bc12-054a9ac16117	2024-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	A-S Medication Solutions	9d4b1225-e20d-4ace-850a-506fd031cac7	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	NuCare Pharmaceuticals,Inc.	79ef87c3-1f09-1625-e053-2991aa0a84ae	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527
Ofloxacin Otic	OFLOXACIN	Proficient Rx LP	14e6e355-3a87-43dc-80a2-070b9df93bf1	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076527 application number: ANDA076527

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Otic Solution 0.3%	Preferred Pharmaceuticals, Inc.	2019-02-06	HUMAN PRESCRIPTION DRUG LABEL	4