Levofloxacin

Product NDC: 50090-3245
11-digit product format: 500903245
Labeler code: 50090
Product ID: 50090-3245_f0b328c3-8092-456e-a360-43166366b1ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202801
Marketing category: ANDA
Marketing start: 2015-01-09
Substance: LEVOFLOXACIN
Active strength: 250 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 package	package	50090-3245	50090-3245-0	D	Discontinued by firm		2026-08-17
excluded package	package	50090-3245	50090-3245-1	D	Discontinued by firm		2026-08-17

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 · 34 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 package	package	50090-3245-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3245-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3245-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3245-0	`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	50090-3245-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3245-1	`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	50090-3245-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3245-1	`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	50090-3245-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3245-1	`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	50090-3245-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3245-1	`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	50090-3245-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3245-1	`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	50090-3245-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3245-1	`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	50090-3245-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3245-1	`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	50090-3245-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3245-1	`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	50090-3245-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3245-1	`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	50090-3245-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3245-1	`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
A202801-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08
A202801-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08
A202801-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202801-001	AB
A202801-002	AB
A202801-003	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	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202801-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2015-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202801-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2015-01-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202801-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2015-01-08	`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	A202801-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202801-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202801-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202801-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202801-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202801-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202801-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202801-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202801-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202801-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202801-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202801-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202801-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202801-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202801-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202801-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202801-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202801-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202801-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202801-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levofloxacin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOFLOXACIN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6GNT3Y5LMF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199884	Internal RxNorm lookup
199885	Internal RxNorm lookup
311296	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1538ec66-f385-401e-8cfb-d794691e7176	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-3245-0	Levofloxacin	3 in 1 BOTTLE	TABLET, FILM COATED	3	27
50090-3245-1	Levofloxacin	10 in 1 BOTTLE	TABLET, FILM COATED	10	27
50090-3245-2	Levofloxacin	7 in 1 BOTTLE	TABLET, FILM COATED	7	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3245-1	EA - Each	50090-3245	812db90e-dc45-4da1-950b-de48697470e8	1	2019-05-02
50090-3245-2	EA - Each	50090-3245	a6a5008b-183d-4deb-a550-e656740e5c04	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3245	LEVOFLOXACIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	20	Current NDC, 3 package rows	20230801_1538ec66-f385-401e-8cfb-d794691e7176.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	2a4e97e0-0709-411b-92e8-6f7d669412e4	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	bcad1dad-53aa-43dd-90f3-cc17cc9598d5	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	Preferred Pharmaceuticals, Inc.	2a8676a9-247f-4fdb-b644-e9785d98771f	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
LEVOFLOXACIN	LEVOFLOXACIN	DIRECT RX	4f40d5fa-ebcc-516c-e054-00144ff8d46c	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	b8ac5047-5203-42c4-886b-dd0b08a1786f	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	16d51c1c-4144-4be7-9356-98fcee621ecd	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	ST. MARY'S MEDICAL PARK PHARMACY	46a3c619-b2a3-3f28-e063-6394a90a2309	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	c6027cde-b9fe-e593-e053-2995a90ac2c1	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	VERITYRX, LLC	427a2077-5dbb-3c5e-e063-6294a90a0839	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	A-S Medication Solutions	1538ec66-f385-401e-8cfb-d794691e7176	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801 ndc (product): 50090-3245
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	64141d0d-0347-470f-a427-9925a2eb357e	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	05d179f5-b200-8597-e063-6394a90a10cc	2025-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	80501b71-2f08-2ef5-e053-2991aa0a6e86	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	DirectRx	dabedb15-5b55-3853-e053-2995a90aa44e	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	d98cf024-51fa-45a1-b247-da55aba88ca0	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	NuCare Pharmaceuticals,Inc.	8423b021-e09c-4f1c-e053-2991aa0afef6	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4b7333-4f77-4ec9-e053-2a95a90a16d2	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	Advanced Rx of Tennessee, LLC	b001d60e-b8fb-54ff-e053-2a95a90a2970	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	A-S Medication Solutions	bdc8b2cc-a914-4613-ac7c-e8dfe91dea13	2024-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801
Levofloxacin	LEVOFLOXACIN	Bryant Ranch Prepack	171ab6c6-8eb5-4716-926f-cee52b7d0968	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202801 application number: ANDA202801

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	1538ec66-f385-401e-8cfb-d794691e7176	27
199885	levoFLOXacin 500 MG Oral Tablet	PSN	1538ec66-f385-401e-8cfb-d794691e7176	27
311296	levoFLOXacin 750 MG Oral Tablet	PSN	1538ec66-f385-401e-8cfb-d794691e7176	27
199884	levofloxacin 250 MG Oral Tablet	SCD	1538ec66-f385-401e-8cfb-d794691e7176	27
199885	levofloxacin 500 MG Oral Tablet	SCD	1538ec66-f385-401e-8cfb-d794691e7176	27
311296	levofloxacin 750 MG Oral Tablet	SCD	1538ec66-f385-401e-8cfb-d794691e7176	27
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	1538ec66-f385-401e-8cfb-d794691e7176	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-3245-0	50090324500	3 in 1 BOTTLE				Historical
50090-3245-1	50090324501	10 in 1 BOTTLE				Historical
50090-3245-2	50090324502	7 TABLET, FILM COATED in 1 BOTTLE (50090-3245-2)	2025-07-17	No	No	Current