LEVOFLOXACIN

Product NDC: 58517-220
11-digit product format: 585170220
Labeler code: 58517
Product ID: 58517-220_a13d2414-c7fe-4202-9cb4-a78984cb1fba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOFLOXACIN
Dosage form: TABLET
Route: ORAL
Labeler: New Horizon Rx Group, LLC
Application: ANDA090722
Marketing category: ANDA
Marketing start: 2013-08-25
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	58517-220		I	Inactivated by FDA		2026-08-03
excluded package	package	58517-220	58517-220-20	I	Inactivated by FDA		2026-08-03

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 · 44 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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`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	58517-220-20	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58517-220-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58517-220-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58517-220-20	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58517-220-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58517-220-20	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58517-220-20	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	58517-220-20	`110d247fa046…`	`a55b01930146…`

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
A090722-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20
A090722-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20
A090722-003	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	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090722-002	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090722-003	LEVOFLOXACIN	750MG	TABLET / ORAL	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090722-001	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090722-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090722-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090722-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A090722-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090722-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090722-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090722-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090722-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090722-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090722-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090722-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090722-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090722-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090722-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090722-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090722-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090722-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090722-003	AB	1	`ea99ee380514…`

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
58517-220-20	2019-11-27	C162847	48780-1	9855e2a2-4794-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN (LEVOFLOXACIN) TABLET for ORAL use. Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58517-220-20	LEVOFLOXACIN	20 in 1 BOTTLE	TABLET	20		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58517-220-20	EA - Each	58517-220	4a501cf3-7262-4a84-b009-94f4298abf5d	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58517-220	LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]	3	Legacy NDC, 1 package rows	20131231_cbcf5738-9a6a-4ff8-ab44-80cc587fa832.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
199885	levoFLOXacin 500 MG Oral Tablet	PSN	cbcf5738-9a6a-4ff8-ab44-80cc587fa832	3
199885	levofloxacin 500 MG Oral Tablet	SCD	cbcf5738-9a6a-4ff8-ab44-80cc587fa832	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58517-220-20	58517022020	20 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVOFLOXACIN	New Horizon Rx Group, LLC \| Torrent Pharmaceuticals Limited	2013-12-31	HUMAN PRESCRIPTION DRUG LABEL	3