Levofloxacin

Product NDC: 51407-428
11-digit product format: 514070428
Labeler code: 51407
Product ID: 51407-428_22436046-c970-53e0-e063-6394a90ade5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA076710
Marketing category: ANDA
Marketing start: 2011-06-20
Substance: LEVOFLOXACIN
Active strength: 250 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A076710-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20
A076710-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20
A076710-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	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
A076710-001	AB
A076710-002	AB
A076710-003	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	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076710-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076710-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076710-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2011-06-20	`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	A076710-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076710-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076710-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076710-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076710-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076710-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076710-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076710-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076710-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076710-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076710-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076710-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076710-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076710-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076710-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076710-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076710-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076710-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076710-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076710-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076710-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076710-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076710-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076710-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076710-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076710-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076710-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076710-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076710-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076710-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076710-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076710-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076710-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076710-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076710-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076710-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076710-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076710-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076710-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076710-001	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
bfe280be-0789-69fa-e053-2a95a90a0e13	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	Strength	SPL version
51407-428-50	Levofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-428-50	EA - Each	51407-428	7c8f59e8-5bbc-4ab9-93a6-ce8b05eb3c20	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-428	LEVOFLOXACIN TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241027_bfe280be-0789-69fa-e053-2a95a90a0e13.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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	710c0c10-89a5-4954-8f74-acc187c5cf0f	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	f14cf651-a213-4a4f-adb9-f628562af27c	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710
Levofloxacin	LEVOFLOXACIN	Cardinal Health 107, LLC	070375be-3b67-4299-ae8f-4a7b157ac16f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f2f090c2-3ee1-7689-e053-2995a90abe38	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f780bb91-483a-d1a6-e053-6294a90ab74b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710
Levofloxacin	LEVOFLOXACIN	Northwind Health Company, LLC	f33140d5-59ad-3379-e053-2995a90ae286	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710
Levofloxacin	LEVOFLOXACIN	Major Pharmaceuticals	ac4001ca-882f-4d9b-a570-c1b9d7fd6830	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710
Levofloxacin	LEVOFLOXACIN	Golden State Medical Supply, Inc.	bfe280be-0789-69fa-e053-2a95a90a0e13	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710 ndc (product): 51407-428
Levofloxacin	LEVOFLOXACIN	Dr. Reddy's Laboratories Limited	9b59428a-a23a-b2d9-982f-98f8a1ed381f	2024-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076710 application number: ANDA076710

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	bfe280be-0789-69fa-e053-2a95a90a0e13	5
199885	levoFLOXacin 500 MG Oral Tablet	PSN	bfe280be-0789-69fa-e053-2a95a90a0e13	5
311296	levoFLOXacin 750 MG Oral Tablet	PSN	bfe280be-0789-69fa-e053-2a95a90a0e13	5
199884	levofloxacin 250 MG Oral Tablet	SCD	bfe280be-0789-69fa-e053-2a95a90a0e13	5
199885	levofloxacin 500 MG Oral Tablet	SCD	bfe280be-0789-69fa-e053-2a95a90a0e13	5
311296	levofloxacin 750 MG Oral Tablet	SCD	bfe280be-0789-69fa-e053-2a95a90a0e13	5
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	bfe280be-0789-69fa-e053-2a95a90a0e13	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-428-50	51407042850	50 TABLET, FILM COATED in 1 BOTTLE (51407-428-50)	2021-03-31	0000-00-00	No	No	Current