Levofloxacin

Product NDC: 64679-545
11-digit product format: 646790545
Labeler code: 64679
Product ID: 64679-545_20ea0c1f-04a1-477d-a25b-ab02113e59cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET
Route: ORAL
Labeler: Wockhardt USA LLC.
Application: ANDA090367
Marketing category: ANDA
Marketing start: 2011-06-20
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64679-545		D	Discontinued by firm	2026-10-05
excluded package	package	64679-545	64679-545-01	D	Discontinued by firm	2026-10-05
excluded package	package	64679-545	64679-545-02	D	Discontinued by firm	2026-10-05
excluded package	package	64679-545	64679-545-03	D	Discontinued by firm	2026-10-05
excluded package	package	64679-545	64679-545-04	D	Discontinued by firm	2026-10-05
excluded package	package	64679-545	64679-545-05	D	Discontinued by firm	2026-10-05

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 3 · 126 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-545-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-545-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-545-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-545-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-545-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-545-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-545-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-545-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-545-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-545-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-545-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-545-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-545-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-545-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-545-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-545-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-545-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-545-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-545-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-545-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-545-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-545-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-545-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-545-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-545-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-545-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-545-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-545-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-545-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-545-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-545-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-545-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-545-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-545-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-545-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-545-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-545-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-545-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-545-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-545-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-545-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-545-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-545-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-545-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-545-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-545-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-545-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-545-03	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-545-04	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-545-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090367-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20
A090367-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20
A090367-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090367-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090367-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090367-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090367-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090367-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090367-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090367-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090367-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090367-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090367-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090367-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090367-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090367-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090367-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090367-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090367-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090367-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090367-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090367-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090367-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090367-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090367-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090367-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090367-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090367-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090367-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090367-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090367-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090367-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090367-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090367-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090367-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090367-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090367-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090367-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090367-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090367-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090367-003	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3	Product name	2	20210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90c	Product name	4	20200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d	Product name	1	20190618
aea4a616-4dfe-45f6-94bb-8b9063056ceb	Product name	6	20190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1	Product name	1	20180821
5a6c788d-375b-4565-a8ae-67c179a30c93	Product name	1	20180212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-545-01	2024-11-15	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-02	2024-11-15	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-03	2024-11-15	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-04	2024-11-15	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-05	2024-11-15	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-01	2020-01-31	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-02	2020-01-31	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-03	2020-01-31	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-04	2020-01-31	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
64679-545-05	2020-01-31	These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-545-02	EA - Each	64679-545	6161c8b1-5760-4995-9f87-23023470cad3	1	2012-07-24
64679-545-03	EA - Each	64679-545	afc254ca-b0b9-46b1-8cf6-b9cc3fab776f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET [WOCKHARDT USA LLC.]	3
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6GNT3Y5LMF	LEVOFLOXACIN	138199-71-0	LEVOFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199884	levoFLOXacin 250 MG Oral Tablet	PSN	56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b	1
199885	levoFLOXacin 500 MG Oral Tablet	PSN	56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b	1
311296	levoFLOXacin 750 MG Oral Tablet	PSN	56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b	1
199884	levofloxacin 250 MG Oral Tablet	SCD	56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b	1
199885	levofloxacin 500 MG Oral Tablet	SCD	56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b	1
311296	levofloxacin 750 MG Oral Tablet	SCD	56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b	1
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	Wockhardt USA LLC. \| Wockhardt Limited	2017-12-06	HUMAN PRESCRIPTION DRUG LABEL	4
Levofloxacin	Aidarex Pharmaceuticals LLC	2014-01-08	HUMAN PRESCRIPTION DRUG LABEL	1