Levofloxacin

Product NDC: 65862-537
Requested package NDC: 65862-537-62
11-digit product format: 658620537
Labeler code: 65862
Product ID: 65862-537_00620274-6cae-4cb8-bd5d-8f80732ae3ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA201043
Marketing category: ANDA
Marketing start: 2011-06-20
Substance: LEVOFLOXACIN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished package	package	65862-537	65862-537-62	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`

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	TE codes	RLD / RS	Approval date
A201043-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20
A201043-002	LEVOFLOXACIN	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20
A201043-003	LEVOFLOXACIN	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	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
A201043-001	AB
A201043-002	AB
A201043-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-002	LEVOFLOXACIN	500MG	TABLET / ORAL	AB		2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-003	LEVOFLOXACIN	750MG	TABLET / ORAL	AB	RS	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201043-001	LEVOFLOXACIN	250MG	TABLET / ORAL	AB		2011-06-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201043-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201043-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201043-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201043-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201043-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201043-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201043-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201043-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201043-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201043-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201043-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201043-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201043-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201043-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201043-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201043-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201043-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levofloxacin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOFLOXACIN	500 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
529ac72c-c4a0-4001-8cf9-b94f5bf7265c	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	SPL version
65862-537-10	Levofloxacin	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	23
65862-537-10	Levofloxacin	10 in 1 CARTON	TABLET, FILM COATED	10	23
65862-537-50	Levofloxacin	50 in 1 BOTTLE	TABLET, FILM COATED	50	23
65862-537-99	Levofloxacin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-537-50	EA - Each	65862-537	4ee5ad1c-8f82-497f-bd52-2c12a064e232	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	9
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	8
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOFLOXACIN TABLET, FILM COATED [READYMEDS]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-537	LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	23	Current NDC, Legacy NDC, 4 package rows	20240630_529ac72c-c4a0-4001-8cf9-b94f5bf7265c.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	HAWAII REPACK, INC.	857f256c-88ac-4f73-9815-c2724edf2f1e	2026-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	REMEDYREPACK INC.	9f944b63-9b60-437a-ba57-d14d7976bc32	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	a5ae33ad-4703-4cb2-8618-6439c906be99	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	814450ae-439e-4a5d-8c60-9b21b6f14be5	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	PD-Rx Pharmaceuticals, Inc.	b8defac4-9deb-433b-928e-0ef4ee0123a2	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Advanced Rx of Tennessee, LLC	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Aurobindo Pharma Limited	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043 ndc (product): 65862-537
Levofloxacin	LEVOFLOXACIN	Asclemed USA, Inc.	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	2024-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043
Levofloxacin	LEVOFLOXACIN	Proficient Rx LP	30958610-3803-45e6-aa3c-d256decbe6e4	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201043 application number: ANDA201043

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	a5ae33ad-4703-4cb2-8618-6439c906be99	31
199885	levofloxacin 500 MG Oral Tablet	SCD	a5ae33ad-4703-4cb2-8618-6439c906be99	31
199885	levoFLOXacin 500 MG Oral Tablet	PSN	b8defac4-9deb-433b-928e-0ef4ee0123a2	30
199885	levofloxacin 500 MG Oral Tablet	SCD	b8defac4-9deb-433b-928e-0ef4ee0123a2	30
199885	levoFLOXacin 500 MG Oral Tablet	PSN	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	24
199885	levofloxacin 500 MG Oral Tablet	SCD	b1a4aabb-42af-4133-8e82-0c7ec8fa79c3	24
199884	levoFLOXacin 250 MG Oral Tablet	PSN	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199885	levoFLOXacin 500 MG Oral Tablet	PSN	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
311296	levoFLOXacin 750 MG Oral Tablet	PSN	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199884	levofloxacin 250 MG Oral Tablet	SCD	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199885	levofloxacin 500 MG Oral Tablet	SCD	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
311296	levofloxacin 750 MG Oral Tablet	SCD	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	529ac72c-c4a0-4001-8cf9-b94f5bf7265c	23
199885	levoFLOXacin 500 MG Oral Tablet	PSN	52687d77-247e-44e8-ae46-3abd3a2505ce	9
199885	levofloxacin 500 MG Oral Tablet	SCD	52687d77-247e-44e8-ae46-3abd3a2505ce	9
199885	levoFLOXacin 500 MG Oral Tablet	PSN	479cf183-88e5-4d57-bc08-22943e63c16c	7
199885	levofloxacin 500 MG Oral Tablet	SCD	479cf183-88e5-4d57-bc08-22943e63c16c	7
199885	levoFLOXacin 500 MG Oral Tablet	PSN	4304fbd4-b0a4-08a6-e054-00144ff88e88	6
199885	levoFLOXacin 500 MG Oral Tablet	PSN	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	6
199885	levoFLOXacin 500 MG Oral Tablet	PSN	9f944b63-9b60-437a-ba57-d14d7976bc32	6
199885	levofloxacin 500 MG Oral Tablet	SCD	afd5cb35-4232-f8b1-e053-2a95a90a8c5b	6
199885	levofloxacin 500 MG Oral Tablet	SCD	4304fbd4-b0a4-08a6-e054-00144ff88e88	6
199885	levofloxacin 500 MG Oral Tablet	SCD	9f944b63-9b60-437a-ba57-d14d7976bc32	6
199885	levoFLOXacin 500 MG Oral Tablet	PSN	638e4e2c-ba0d-43f7-87a0-1b860a9e651a	3
199885	levofloxacin 500 MG Oral Tablet	SCD	638e4e2c-ba0d-43f7-87a0-1b860a9e651a	3
199884	levoFLOXacin 250 MG Oral Tablet	PSN	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199885	levoFLOXacin 500 MG Oral Tablet	PSN	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
311296	levoFLOXacin 750 MG Oral Tablet	PSN	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199884	levofloxacin 250 MG Oral Tablet	SCD	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199885	levofloxacin 500 MG Oral Tablet	SCD	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
311296	levofloxacin 750 MG Oral Tablet	SCD	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1
199884	levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet	SY	2e32a8aa-047b-46c6-b67b-d88a9a0a810b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-537-62	65862053762	30000 TABLET, FILM COATED in 1 BAG (65862-537-62)	07-JAN-22	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	HAWAII REPACK, INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-07-18	HUMAN PRESCRIPTION DRUG LABEL	1
Levofloxacin	REMEDYREPACK INC.	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	6
Levofloxacin	PD-Rx Pharmaceuticals, Inc.	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	31
Levofloxacin	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	24
Levofloxacin	PD-Rx Pharmaceuticals, Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	30
Levofloxacin 500mg Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Levofloxacin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	6
Levofloxacin	Aurobindo Pharma Limited \| Aurolife Pharma LLC \| APL HEALTHCARE LIMITED	2024-06-20	Human Prescription Drug Label	23
Levofloxacin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-05-13	HUMAN PRESCRIPTION DRUG LABEL	1
Levofloxacin	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	3
Levofloxacin	A-S Medication Solutions	2021-08-06	Human Prescription Drug Label	20
Levofloxacin	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Levofloxacin	NuCare Pharmaceuticals,Inc.	2019-06-17	HUMAN PRESCRIPTION DRUG LABEL	1
Levofloxacin	A-S Medication Solutions	2017-11-16	Human Prescription Drug Label	5
Levofloxacin	Blenheim Pharmacal, Inc.	2015-09-11	Human Prescription Drug Label	9
Levofloxacin	ReadyMeds	2014-05-05	Human Prescription Drug Label	7