Levofloxacin

Product NDC: 52343-119
11-digit product format: 523430119
Labeler code: 52343
Product ID: 52343-119_341ba2e9-97b7-44a3-a4fc-f159bbab9a5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ACETRIS HEALTH, LLC
Application: ANDA201043
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52343-119		D	Discontinued by firm		2026-08-11
excluded package	package	52343-119	52343-119-50	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`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	52343-119-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	TE codes	RLD / RS	Approval date
A201043-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20
A201043-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20
A201043-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201043-001	AB
A201043-002	AB
A201043-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A201043-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201043-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201043-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201043-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52343-119-50	EA - Each	52343-119	ea42eaa4-e68c-4a30-a6d8-6fff094ded8d	1	2016-07-19

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	HAWAII REPACK, INC.	857f256c-88ac-4f73-9815-c2724edf2f1e	2026-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	9f944b63-9b60-437a-ba57-d14d7976bc32	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	a5ae33ad-4703-4cb2-8618-6439c906be99	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	814450ae-439e-4a5d-8c60-9b21b6f14be5	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b8defac4-9deb-433b-928e-0ef4ee0123a2	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Advanced Rx of Tennessee, LLC	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Aurobindo Pharma Limited	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Asclemed USA, Inc.	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	2024-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	30958610-3803-45e6-aa3c-d256decbe6e4	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52343-119-50	52343011950	50 TABLET, FILM COATED in 1 BOTTLE (52343-119-50)	2011-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	ACETRIS HEALTH, LLC \| Aurolife Pharma, LLC \| Aurobindo Pharma Limited	2019-10-28	Human Prescription Drug Label	5