LEVOFLOXACIN TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-05-31 21:11:01

Label at a glance#

Productlevofloxacin

Active ingredientLEVOFLOXACIN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-691-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 250 mg

Rx only

50 tablets

NDC 65841-692-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 500 mg

Rx only

50 tablets

NDC 65841-693-06 in bottle of 30 tablets

Levofloxacin Tablets USP, 750 mg

Rx only

30 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199884	levoFLOXacin 250 MG Oral Tablet	PSN	11
199885	levoFLOXacin 500 MG Oral Tablet	PSN	11
311296	levoFLOXacin 750 MG Oral Tablet	PSN	11
199884	levofloxacin 250 MG Oral Tablet	SCD	11
199885	levofloxacin 500 MG Oral Tablet	SCD	11
311296	levofloxacin 750 MG Oral Tablet	SCD	11
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	11

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
65841-691-01	levofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65841-691-05	levofloxacin	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
65841-691-18	levofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50	11
65841-692-01	levofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65841-692-05	levofloxacin	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
65841-692-10	levofloxacin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	11
65841-692-18	levofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50	11
65841-693-01	levofloxacin	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65841-693-05	levofloxacin	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
65841-693-06	levofloxacin	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
65841-693-18	levofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50	11
65841-693-92	levofloxacin	20 in 1 BOTTLE	TABLET, FILM COATED	20	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-691	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 3 package rows	20240821_ffa121b8-388f-4d7b-af48-d4aa8d9b5961.zip
65841-692	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 4 package rows	20240821_ffa121b8-388f-4d7b-af48-d4aa8d9b5961.zip
65841-693	LEVOFLOXACIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	11	Current NDC, Legacy NDC, 5 package rows	20240821_ffa121b8-388f-4d7b-af48-d4aa8d9b5961.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	1
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

levofloxacin
LEVOFLOXACIN ANHYDROUS
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-691	65841-691-18, 65841-691-01, 65841-691-05
65841-692	65841-692-18, 65841-692-01, 65841-692-05, 65841-692-10
65841-693	65841-693-18, 65841-693-01, 65841-693-05, 65841-693-92, 65841-693-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LEVOFLOXACIN	6GNT3Y5LMF	ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LEVOFLOXACIN	6GNT3Y5LMF	ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LEVOFLOXACIN	6GNT3Y5LMF	ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 90 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL	91 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL	36 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL	582 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL	132 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL	992 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL	96 mg	Exact identifier — unii+route+dosage form 15 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077652-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07
A077652-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07
A077652-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077652-001	AB
A077652-002	AB
A077652-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	2012-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB	2012-09-07	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077652-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077652-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077652-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077652-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077652-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077652-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077652-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077652-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077652-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077652-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077652-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077652-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077652-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077652-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077652-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077652-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077652-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077652-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077652-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077652-001	AB	1	`301d65b070ca…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levofloxacin	LEVOFLOXACIN	Zydus Lifesciences Limited	ffa121b8-388f-4d7b-af48-d4aa8d9b5961	2024-08-16		Exact identifier ndc (package): 65841-691-18 ndc (package): 65841-691-05 ndc (package): 65841-692-18 ndc (package): 65841-693-05 ndc (package): 65841-693-01 ndc (package): 65841-693-92 ndc (package): 65841-693-06 ndc (package): 65841-692-10 ndc (package): 65841-693-18 ndc (package): 65841-692-05 ndc (package): 65841-691-01 ndc (package): 65841-692-01 ndc (product): 65841-691 ndc (product): 65841-692 ndc (product): 65841-693 ndc11 (package): 65841069218 ndc11 (package): 65841069101 ndc11 (package): 65841069205 ndc11 (package): 65841069305 ndc11 (package): 65841069118 ndc11 (package): 65841069201 ndc11 (package): 65841069105 ndc11 (package): 65841069306 ndc11 (package): 65841069301 ndc11 (package): 65841069392 ndc11 (package): 65841069318 ndc11 (package): 65841069210 spl id: 5aeae448-e53f-4954-9dd9-2bcc3dd791d4 spl set id: ffa121b8-388f-4d7b-af48-d4aa8d9b5961

Reported adverse events (FAERS/openFDA)#

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