Levofloxacin

Product NDC: 33261-891
11-digit product format: 332610891
Labeler code: 33261
Product ID: 33261-891_5de98130-babf-405b-994a-d117eef9ef57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA090367
Marketing category: ANDA
Marketing start: 2011-06-20
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 250 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-891		I	Inactivated by FDA	2026-08-07
excluded package	package	33261-891	33261-891-10	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-891	33261-891-20	I	Inactivated by FDA	2026-08-07
excluded package	package	33261-891	33261-891-30	I	Inactivated by FDA	2026-08-07

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 · 84 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	33261-891-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-891-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-891-20	`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	33261-891-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-891-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-891-20	`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	33261-891-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-891-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-891-20	`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	33261-891-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-891-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-891-20	`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	33261-891-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-891-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-891-20	`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	33261-891-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-891-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-891-20	`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	33261-891-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-891-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-891-20	`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	33261-891-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-891-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-891-20	`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	33261-891-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-891-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-891-20	`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	33261-891-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-891-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-891-20	`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	33261-891-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-891-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-891-20	`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	33261-891-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-891-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-891-20	`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	33261-891-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-891-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-891-20	`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	33261-891-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-891-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-891-20	`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	33261-891-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-891-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-891-20	`1332a3947898…`	`d4bfe170f9cd…`

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

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090367-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090367-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090367-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090367-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090367-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090367-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090367-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090367-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090367-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090367-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090367-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090367-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090367-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090367-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090367-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090367-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090367-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090367-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090367-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090367-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090367-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090367-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090367-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090367-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090367-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090367-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090367-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090367-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090367-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090367-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090367-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090367-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090367-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090367-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090367-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090367-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090367-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090367-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090367-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090367-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090367-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090367-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090367-001	AB	1	`6a51e52b5d6a…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-891-10	2020-01-31	C162847	48780-1	9d75b9d0-75df-f424-e053-dadaa90a57ce	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
33261-891-20	2020-01-31	C162847	48780-1	9d75b9d0-75df-f424-e053-dadaa90a57ce	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
33261-891-30	2020-01-31	C162847	48780-1	9d75b9d0-75df-f424-e053-dadaa90a57ce	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-891-10	Levofloxacin	10 in 1 BOTTLE, PLASTIC	TABLET	10	1
33261-891-20	Levofloxacin	20 in 1 BOTTLE, PLASTIC	TABLET	20	1
33261-891-30	Levofloxacin	30 in 1 BOTTLE, PLASTIC	TABLET	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-891-10	EA - Each	33261-891	b9d5c2f3-ecec-4612-8807-529134dd03fc	1	2015-10-02
33261-891-20	EA - Each	33261-891	87afb4a8-6ac2-4b6a-a771-8cfeeb653060	1	2016-09-02
33261-891-30	EA - Each	33261-891	37bf3623-8bbb-4188-9ce9-e7f1f311da7d	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-891	LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 3 package rows	20140110_56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-891-10	33261089110	10 in 1 BOTTLE, PLASTIC	Historical
33261-891-20	33261089120	20 in 1 BOTTLE, PLASTIC	Historical
33261-891-30	33261089130	30 in 1 BOTTLE, PLASTIC	Historical