levofloxacin

Product NDC
67296-1123
11-digit product format
672961123
Labeler code
67296
Product ID
67296-1123_9c9ef8d5-173f-a96d-e053-2995a90a1c70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077652
Marketing category
ANDA
Marketing start
2012-11-10
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1123IInactivated by FDA2026-09-09
excluded packagepackage67296-112367296-1123-1IInactivated by FDA2026-09-09
excluded packagepackage67296-112367296-1123-7IInactivated by FDA2026-09-09

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 · 57 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1123-7IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1123-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1123-7IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1123-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1123-7IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1123-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1123-7IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1123-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1123-7IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1123-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1123-7IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1123-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1123-7IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1123-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1123-7IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1123-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1123-7IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1123-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1123-7IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1123-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1123-7IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1123-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1123-7IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1123-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1123-7IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1123-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1123-7IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1123-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1123-7IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1123-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1123-7IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1123-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-1123-7IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-1123-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-1123-7IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-1123-1IInactivated by FDAbd6a592717d7…303034d00443…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1123-7EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1123-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A077652-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2012-09-07
A077652-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2012-09-07
A077652-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2012-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077652-001AB
A077652-002AB
A077652-003AB

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 06:07:402026-07A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-071e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077652-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077652-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077652-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077652-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077652-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1123-12022-01-28C16284748780-1d6a99b39-b656-a426-e053-dadaa90af4c24ea466dd-62cc-6ba1-e054-00144ff8d46c
67296-1123-72022-01-28C16284748780-1d6a99b39-b656-a426-e053-dadaa90af4c24ea466dd-62cc-6ba1-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1123-1levofloxacin10 in 1 BOTTLETABLET, FILM COATED102
67296-1123-7levofloxacin7 in 1 BOTTLETABLET, FILM COATED72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1123LEVOFLOXACIN TABLET, FILM COATED [REDPHARM DRUG, INC.]2Legacy NDC, 2 package rows20200121_4ea466dd-62cc-6ba1-e054-00144ff8d46c.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levofloxacinLEVOFLOXACINBryant Ranch Prepackb9dc8bf3-97d9-4d1c-9a68-3ae553acdada2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackcbd5153f-fada-4682-b858-dc3b6e3173cc2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINCoupler LLC2cee61b7-be51-0fe5-e063-6294a90af9e32025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc067e260c-dc47-4957-a9ff-5a79f17b4ca02025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackb7a614b0-f604-48e1-9919-21da8f939d932024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Exact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
LevofloxacinLLEVOFLOXACINAdvanced Rx Pharmacy of Tennessee, LLC19afbe98-484c-c980-e063-6294a90acdc62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN4ea466dd-62cc-6ba1-e054-00144ff8d46c2
199885levofloxacin 500 MG Oral TabletSCD4ea466dd-62cc-6ba1-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1123-16729611230110 TABLET, FILM COATED in 1 BOTTLE (67296-1123-1) 2012-11-100000-00-00NoNoCurrent
67296-1123-7672961123077 TABLET, FILM COATED in 1 BOTTLE (67296-1123-7) 2012-11-100000-00-00NoNoCurrent