ofloxacin

Product NDC: 52959-763
11-digit product format: 529590763
Labeler code: 52959
Product ID: 52959-763_b0521d4d-afba-41bf-a921-1dc4a277e5f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ofloxacin
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: H.J. Harkins Company, Inc.
Application: ANDA078559
Marketing category: ANDA
Marketing start: 2010-01-04
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-763		I	Inactivated by FDA	2026-08-11
excluded package	package	52959-763	52959-763-05	I	Inactivated by FDA	2026-08-11
excluded package	package	52959-763	52959-763-10	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 2 · 66 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	52959-763-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-763-05	`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	52959-763-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-763-05	`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	52959-763-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-763-05	`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	52959-763-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-763-05	`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	52959-763-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-763-05	`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	52959-763-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-763-05	`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	52959-763-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-763-05	`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	52959-763-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-763-05	`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	52959-763-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-763-05	`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	52959-763-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-763-05	`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	52959-763-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-763-05	`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	52959-763-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-763-05	`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	52959-763-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-763-05	`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	52959-763-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-763-05	`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	52959-763-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-763-05	`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	52959-763-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52959-763-10	`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	52959-763-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52959-763-10	`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	52959-763-05	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52959-763-10	`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	52959-763-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52959-763-10	`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	52959-763-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-763-10	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

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
41679fed-052c-574b-6b40-cadcbc315b79	Product name	2	20150401

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-763-05	2019-11-13	C162847	48780-1	97449f38-b7b6-f6ea-e053-dbdaa90aa703	Ofloxacin Ophthalmic Solution USP 0.3%
52959-763-10	2019-11-13	C162847	48780-1	97449f38-b7b6-f6ea-e053-dbdaa90aa703	Ofloxacin Ophthalmic Solution USP 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-763-05	ofloxacin	1 in 1 CARTON	SOLUTION	1	21
52959-763-05	ofloxacin	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5	21
52959-763-10	ofloxacin	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10	21
52959-763-10	ofloxacin	1 in 1 CARTON	SOLUTION	1	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-763-05	ML - Milliliter	52959-763	05c6bd80-ad87-480d-9666-402eea277bc5	1	2012-07-24
52959-763-10	ML - Milliliter	52959-763	04a1c6c5-aa3b-426c-92c6-b5e2d18ad77c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ofloxacin	ACTIVE INGREDIENT	A4P49JAZ9H	OFLOXACIN SOLUTION [H.J. HARKINS COMPANY, INC.]	21
ofloxacin	ACTIVE MOIETY	A4P49JAZ9H	OFLOXACIN SOLUTION [H.J. HARKINS COMPANY, INC.]	21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-763	OFLOXACIN SOLUTION [H.J. HARKINS COMPANY, INC.]	21	Legacy NDC, 4 package rows	20111229_557b44ee-bea9-4dfe-866b-f0e3d8fcd018.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312075	ofloxacin 0.3 % Ophthalmic Solution	PSN	557b44ee-bea9-4dfe-866b-f0e3d8fcd018	21
312075	ofloxacin 3 MG/ML Ophthalmic Solution	SCD	557b44ee-bea9-4dfe-866b-f0e3d8fcd018	21
312075	ofloxacin 0.3 % Ophthalmic Solution	SY	557b44ee-bea9-4dfe-866b-f0e3d8fcd018	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52959-763-05	52959076305	1 in 1 CARTON		Historical
52959-763-10	52959076310	10 mL in 1 BOTTLE, PLASTIC	10 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofloxacin Ophthalmic Solution USP 0.3%	H.J. Harkins Company, Inc. \| Pack Pharmaceuticals, LLC \| FDC Limited	2011-09-08	HUMAN PRESCRIPTION DRUG LABEL	21