levofloxacin

Product NDC: 68382-017
11-digit product format: 683820017
Labeler code: 68382
Product ID: 68382-017_6aba6a7e-43d3-41b0-bdc0-a62ffb483919
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA077652
Marketing category: ANDA
Marketing start: 2012-11-10
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 750 mg/1
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-017		D	Discontinued by firm	2026-09-09
excluded package	package	68382-017	68382-017-01	D	Discontinued by firm	2026-09-09
excluded package	package	68382-017	68382-017-05	D	Discontinued by firm	2026-09-09
excluded package	package	68382-017	68382-017-18	D	Discontinued by firm	2026-09-09

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 · 48 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	68382-017-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-017-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-017-05	`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	68382-017-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-017-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-017-05	`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	68382-017-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-017-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-017-05	`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	68382-017-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-017-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-017-05	`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	68382-017-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-017-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-017-05	`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	68382-017-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-017-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-017-05	`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	68382-017-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-017-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-017-05	`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	68382-017-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-017-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-017-05	`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	68382-017-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-017-18	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-017-05	`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	68382-017-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-017-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-017-05	`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	68382-017-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-017-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-017-05	`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	68382-017-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-017-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-017-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A077652-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07
A077652-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07
A077652-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077652-001	AB
A077652-002	AB
A077652-003	AB

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 · 126 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
2026-08-18 06:07:40	2026-07	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077652-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077652-001	AB	1	`1e350fbaab3a…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-017-01	EA - Each	68382-017	a08b5235-1129-40fa-9c69-7c1b4f9b409f	1	2013-02-13
68382-017-18	EA - Each	68382-017	bc5ad1df-871a-4f6a-90dc-f9a3ead0cdb8	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b9dc8bf3-97d9-4d1c-9a68-3ae553acdada	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Redpharm Drug	5261da15-1b6c-fbe2-e063-6394a90ad85e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Redpharm Drug	44f31105-5fc9-43d4-e063-6294a90a510f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	264a3f71-f23e-45e3-926a-421bcccf4e3d	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc.	7a12135e-cbad-4fe1-98f7-53c41d1f2a21	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Redpharm Drug	301ecffc-ecaf-01de-e063-6294a90a61b3	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	cbd5153f-fada-4682-b858-dc3b6e3173cc	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Coupler LLC	2cee61b7-be51-0fe5-e063-6294a90af9e3	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals Inc	067e260c-dc47-4957-a9ff-5a79f17b4ca0	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	b7a614b0-f604-48e1-9919-21da8f939d93	2024-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Zydus Lifesciences Limited	ffa121b8-388f-4d7b-af48-d4aa8d9b5961	2024-08-16		Exact identifier application applno (ANDA): 077652 application number: ANDA077652
levofloxacin	LEVOFLOXACIN	Viona Pharmaceuticals Inc	0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652
Levofloxacin	LLEVOFLOXACIN	Advanced Rx Pharmacy of Tennessee, LLC	19afbe98-484c-c980-e063-6294a90acdc6	2024-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077652 application number: ANDA077652

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
311296	levoFLOXacin 750 MG Oral Tablet	PSN	4ea3cb49-c279-3cac-e054-00144ff88e88	3
311296	levofloxacin 750 MG Oral Tablet	SCD	4ea3cb49-c279-3cac-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-017-01	68382001701	100 TABLET, FILM COATED in 1 BOTTLE (68382-017-01)	2012-11-10	0000-00-00	No	No	Current
68382-017-05	68382001705	500 TABLET, FILM COATED in 1 BOTTLE (68382-017-05)	2012-11-10	0000-00-00	No	No	Current
68382-017-18	68382001718	50 TABLET, FILM COATED in 1 BOTTLE (68382-017-18)	2012-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
levofloxacin	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
levofloxacin	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3
levofloxacin	Bryant Ranch Prepack	2020-09-17	HUMAN PRESCRIPTION DRUG LABEL	5
levofloxacin	Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited	2020-08-11	HUMAN PRESCRIPTION DRUG LABEL	14
levofloxacin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
levofloxacin	QPharma Inc \| Zydus Pharmaceuticals (USA) Inc. \| Denton Pharma, Inc.	2018-04-19	HUMAN PRESCRIPTION DRUG LABEL	1