Levofloxacin

Product NDC
68071-4926
Requested package NDC
68071-4926-3
11-digit product format
680714926
Labeler code
68071
Product ID
68071-4926_bb9f401f-f5fd-5c3e-e053-2a95a90a59a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200839
Marketing category
ANDA
Marketing start
2012-03-22
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 packagepackage68071-492668071-4926-3DDiscontinued 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 1 · 6 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A200839-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2012-03-22
A200839-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2012-03-22
A200839-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2012-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200839-001AB
A200839-002AB
A200839-003AB

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 06:07:402026-07A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-002LEVOFLOXACIN500MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-003LEVOFLOXACIN750MGTABLET / ORALAB2012-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200839-001LEVOFLOXACIN250MGTABLET / ORALAB2012-03-221e350fbaab3a…

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 06:07:402026-07A200839-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200839-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200839-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200839-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200839-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200839-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200839-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200839-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200839-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200839-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200839-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200839-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200839-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200839-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200839-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200839-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200839-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200839-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4926LEVOFLOXACIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC20240820_8b87eb2e-993b-80f6-e053-2a95a90aec8c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINRedpharm Drug0a0fd993-7bea-42d8-e063-6394a90a4e0e2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200839
application number: ANDA200839
LevofloxacinLEVOFLOXACINMacleods Pharmaceuticals Limitedfc165a6d-24b0-4753-a7ac-94a134dca0d32023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200839
application number: ANDA200839

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4926-36807149260330 TABLET, FILM COATED in 1 BOTTLE (68071-4926-3) 2019-06-170000-00-00NoNoCurrent