Levofloxacin

Product NDC
67296-1641
Requested package NDC
67296-1641-3
11-digit product format
672961641
Labeler code
67296
Product ID
67296-1641_b8d08b7b-cc02-9efd-e053-2995a90a89e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA202801
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-164167296-1641-3IInactivated by FDA2026-08-03

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A202801-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2015-01-08
A202801-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2015-01-08
A202801-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2015-01-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202801-001AB
A202801-002AB
A202801-003AB

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 · 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 UTC2026-02A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-088072bd15b7f6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202801-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202801-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202801-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202801-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202801-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202801-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202801-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202801-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202801-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202801-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202801-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202801-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202801-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202801-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202801-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202801-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202801-001AB18072bd15b7f6…

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
67296-1641-32023-01-30C16284748780-1f386c649-b830-0266-e053-dadaa90a7c1aLevofloxacin 250mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1641-3Levofloxacin3 in 1 BOTTLETABLET, FILM COATED36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1641LEVOFLOXACIN TABLET, FILM COATED [REDPHARM DRUG, INC.]6Legacy NDC, 1 package rows20210114_88dedeb8-9649-5849-e053-2995a90aab72.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.2a4e97e0-0709-411b-92e8-6f7d669412e42026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.bcad1dad-53aa-43dd-90f3-cc17cc9598d52026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINPreferred Pharmaceuticals, Inc.2a8676a9-247f-4fdb-b644-e9785d98771f2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LEVOFLOXACINLEVOFLOXACINDIRECT RX4f40d5fa-ebcc-516c-e054-00144ff8d46c2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.b8ac5047-5203-42c4-886b-dd0b08a1786f2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.16d51c1c-4144-4be7-9356-98fcee621ecd2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINST. MARY'S MEDICAL PARK PHARMACY46a3c619-b2a3-3f28-e063-6394a90a23092025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.c6027cde-b9fe-e593-e053-2995a90ac2c12025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINVERITYRX, LLC427a2077-5dbb-3c5e-e063-6294a90a08392025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINA-S Medication Solutions1538ec66-f385-401e-8cfb-d794691e71762025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINProficient Rx LP64141d0d-0347-470f-a427-9925a2eb357e2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.05d179f5-b200-8597-e063-6394a90a10cc2025-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.80501b71-2f08-2ef5-e053-2991aa0a6e862025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINDirectRxdabedb15-5b55-3853-e053-2995a90aa44e2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.d98cf024-51fa-45a1-b247-da55aba88ca02025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINNuCare Pharmaceuticals,Inc.8423b021-e09c-4f1c-e053-2991aa0afef62025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINADVANCED RX PHARMACY OF TENNESSEE, LLCaf4b7333-4f77-4ec9-e053-2a95a90a16d22024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINAdvanced Rx of Tennessee, LLCb001d60e-b8fb-54ff-e053-2a95a90a29702024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINA-S Medication Solutionsbdc8b2cc-a914-4613-ac7c-e8dfe91dea132024-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801
LevofloxacinLEVOFLOXACINBryant Ranch Prepack171ab6c6-8eb5-4716-926f-cee52b7d09682024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202801
application number: ANDA202801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN88dedeb8-9649-5849-e053-2995a90aab726
199884levofloxacin 250 MG Oral TabletSCD88dedeb8-9649-5849-e053-2995a90aab726
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY88dedeb8-9649-5849-e053-2995a90aab726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1641-3672961641033 TABLET, FILM COATED in 1 BOTTLE (67296-1641-3) 2019-01-010000-00-00NoNoCurrent