LEVOFLOXACIN

Product NDC: 63629-4843
Requested package NDC: 63629-4843-3
11-digit product format: 636294843
Labeler code: 63629
Product ID: 63629-4843_87221bce-9484-4092-a96d-538ec08ebf8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOFLOXACIN
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090722
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-4843	63629-4843-3	D	Discontinued by firm		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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	I	Inactivated by FDA	`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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4843-1	2022-02-16	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN Tablets, for oral use Initial U.S. Approval: 1996
63629-4843-2	2022-02-16	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN Tablets, for oral use Initial U.S. Approval: 1996
63629-4843-3	2022-02-16	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN Tablets, for oral use Initial U.S. Approval: 1996
63629-4843-1	2019-11-27	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN Tablets, for oral use Initial U.S. Approval: 1996
63629-4843-2	2019-11-27	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN Tablets, for oral use Initial U.S. Approval: 1996
63629-4843-3	2019-11-27	These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN Tablets, for oral use Initial U.S. Approval: 1996

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4843-1	EA - Each	63629-4843	cee6fe3b-c73b-4d7f-8d97-4820d27a6dbb	1	2015-10-02
63629-4843-2	EA - Each	63629-4843	6c0afb75-8b43-4b6c-8620-d4d977f6c87f	1	2015-10-02
63629-4843-3	EA - Each	63629-4843	a4c6221d-322e-464a-b88d-816845380503	1	2015-10-02
63629-4843-4	EA - Each	63629-4843	dc4dfe87-50c3-435b-8854-584bb61797ef	1	2022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET [BRYANT RANCH PREPACK]	1000

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4843-3	63629484303	60 TABLET in 1 BOTTLE (63629-4843-3)	60 tablet	2022-02-08	0000-00-00	No	No	Current