Levofloxacin

Product NDC
71335-0965
11-digit product format
713350965
Labeler code
71335
Product ID
71335-0965_0b6b5c48-ed42-49c3-81e9-6ec5fea1b744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2021-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0965DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-0DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-7DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-8DDiscontinued by firm2026-08-17
excluded packagepackage71335-096571335-0965-9DDiscontinued by firm2026-08-17

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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0965-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0965-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0965-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0965-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0965-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0965-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0965-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0965-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0965-3cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077438-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORAL2011-06-20
A077438-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORAL2011-06-20
A077438-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORAL2011-06-20

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077438-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077438-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077438-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077438-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077438-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077438-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077438-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077438-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077438-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077438-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077438-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077438-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077438-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077438-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077438-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077438-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077438-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077438-003LEVOFLOXACIN750MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077438-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-201e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077438-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077438-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077438-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077438-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077438-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077438-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077438-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077438-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077438-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077438-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077438-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077438-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077438-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077438-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077438-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077438-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077438-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077438-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077438-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077438-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077438-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077438-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077438-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077438-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077438-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077438-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077438-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077438-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077438-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077438-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077438-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077438-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077438-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077438-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077438-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077438-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077438-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077438-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077438-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077438-001AB187673890dc5c…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0965-07133509650090 TABLET, FILM COATED in 1 BOTTLE (71335-0965-0) 2018-10-110000-00-00NoNoCurrent
71335-0965-17133509650130 TABLET, FILM COATED in 1 BOTTLE (71335-0965-1) 2017-02-140000-00-00NoNoCurrent
71335-0965-27133509650210 TABLET, FILM COATED in 1 BOTTLE (71335-0965-2) 2017-02-140000-00-00NoNoCurrent
71335-0965-3713350965037 TABLET, FILM COATED in 1 BOTTLE (71335-0965-3) 2017-02-140000-00-00NoNoCurrent
71335-0965-47133509650414 TABLET, FILM COATED in 1 BOTTLE (71335-0965-4) 2017-02-140000-00-00NoNoCurrent
71335-0965-5713350965055 TABLET, FILM COATED in 1 BOTTLE (71335-0965-5) 2017-02-140000-00-00NoNoCurrent
71335-0965-67133509650620 TABLET, FILM COATED in 1 BOTTLE (71335-0965-6) 2017-02-140000-00-00NoNoCurrent
71335-0965-77133509650760 TABLET, FILM COATED in 1 BOTTLE (71335-0965-7) 2017-02-140000-00-00NoNoCurrent
71335-0965-8713350965083 TABLET, FILM COATED in 1 BOTTLE (71335-0965-8) 2017-02-140000-00-00NoNoCurrent
71335-0965-97133509650950 TABLET, FILM COATED in 1 BOTTLE (71335-0965-9) 2017-02-140000-00-00NoNoCurrent