Levofloxacin

Product NDC: 63187-003
11-digit product format: 631870003
Labeler code: 63187
Product ID: 63187-003_d3c398d7-5370-40dc-bbe2-8621026bec3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx
Application: ANDA077438
Marketing category: ANDA
Marketing start: 2011-06-20
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 500 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	63187-003		D	Discontinued by firm		2026-10-15
excluded package	package	63187-003	63187-003-10	D	Discontinued by firm		2026-10-15

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-003-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-003-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-003-10	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077438-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	2011-06-20
A077438-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	2011-06-20
A077438-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL		2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077438-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077438-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077438-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077438-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077438-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077438-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077438-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077438-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077438-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077438-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077438-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077438-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077438-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077438-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077438-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077438-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077438-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077438-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077438-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077438-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077438-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077438-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077438-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077438-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077438-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077438-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077438-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077438-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077438-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077438-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077438-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077438-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077438-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077438-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077438-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077438-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077438-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077438-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077438-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077438-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077438-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077438-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077438-002	AB	1	`3f0d92c62455…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63187-003-10	2019-12-10	C162847	48780-1	9855e2a2-3807-60a7-e053-dbdaa90a05bd	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 Initial U.S. Approval: 1996
63187-003-10	2019-11-27	C162847	48780-1	9855e2a2-3807-60a7-e053-dbdaa90a05bd	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 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
63187-003-10	EA - Each	63187-003	7e119f3f-9b42-4882-b882-be643602ab55	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-003	LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]	2	Legacy NDC	20191210_110b351c-fd13-408a-bf08-e47c1fcd8c93.zip

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
63187-003-10	63187000310	10 TABLET, FILM COATED in 1 BOTTLE (63187-003-10)	2014-05-01	0000-00-00	No	No	Current