Levofloxacin

Product NDC
68788-9709
11-digit product format
687889709
Labeler code
68788
Product ID
68788-9709_b5e4ffb7-8759-4769-b8f2-06de435bee0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA090367
Marketing category
ANDA
Marketing start
2013-02-04
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9709DDiscontinued by firm2026-08-10
excluded packagepackage68788-970968788-9709-1DDiscontinued by firm2026-08-10
excluded packagepackage68788-970968788-9709-2DDiscontinued by firm2026-08-10
excluded packagepackage68788-970968788-9709-4DDiscontinued by firm2026-08-10
excluded packagepackage68788-970968788-9709-5DDiscontinued by firm2026-08-10
excluded packagepackage68788-970968788-9709-7DDiscontinued by firm2026-08-10

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 2 · 72 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 packagepackage68788-9709-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9709-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9709-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9709-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9709-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9709-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9709-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9709-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9709-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9709-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9709-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9709-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9709-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9709-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9709-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9709-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9709-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9709-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9709-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9709-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9709-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9709-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9709-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9709-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9709-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9709-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9709-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9709-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9709-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9709-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9709-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9709-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9709-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9709-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9709-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9709-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9709-7ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9709-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9709-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9709-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9709-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9709-70efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9709-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9709-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9709-50efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9709-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9709-7ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9709-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9709-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9709-5ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090367-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORAL2011-06-20
A090367-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORAL2011-06-20
A090367-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / 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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090367-002LEVOFLOXACIN500MGTABLET / ORAL2011-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090367-003LEVOFLOXACIN750MGTABLET / ORAL2011-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090367-001LEVOFLOXACIN250MGTABLET / ORAL2011-06-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090367-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090367-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090367-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090367-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090367-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090367-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090367-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090367-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090367-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090367-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090367-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090367-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090367-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090367-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090367-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090367-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090367-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090367-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090367-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090367-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090367-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090367-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090367-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090367-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090367-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090367-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090367-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090367-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090367-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090367-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090367-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090367-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A090367-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090367-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090367-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090367-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090367-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090367-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090367-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090367-001AB16a51e52b5d6a…