Levofloxacin

Product NDC
67296-0998
11-digit product format
672960998
Labeler code
67296
Product ID
67296-0998_bdad188b-db45-571c-e053-2a95a90ab87b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
750 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-0998IInactivated by FDA2026-08-11
excluded packagepackage67296-099867296-0998-1IInactivated by FDA2026-08-11
excluded packagepackage67296-099867296-0998-5IInactivated by FDA2026-08-11
excluded packagepackage67296-099867296-0998-7IInactivated by FDA2026-08-11

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0998-5557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0998-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0998-7557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0998-58af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0998-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0998-78af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0998-5834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0998-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0998-7834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0998-51332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0998-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0998-71332a3947898…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
A201043-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2011-06-20
A201043-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2011-06-20
A201043-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201043-001AB
A201043-002AB
A201043-003AB

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 UTC2026-02A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-002LEVOFLOXACIN500MGTABLET / ORALAB2011-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-003LEVOFLOXACIN750MGTABLET / ORALABRS2011-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201043-001LEVOFLOXACIN250MGTABLET / ORALAB2011-06-208072bd15b7f6…

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 UTC2026-02A201043-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201043-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201043-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201043-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201043-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201043-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201043-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201043-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201043-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201043-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201043-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201043-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201043-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201043-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201043-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201043-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201043-001AB18072bd15b7f6…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0998-1Levofloxacin10 in 1 BOTTLETABLET, FILM COATED1012
67296-0998-5Levofloxacin5 in 1 BOTTLETABLET, FILM COATED512
67296-0998-7Levofloxacin7 in 1 BOTTLETABLET, FILM COATED712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0998LEVOFLOXACIN TABLET, FILM COATED [REDPHARM DRUG, INC.]12Legacy NDC, 3 package rows20240712_bdad0b58-495d-2352-e053-2a95a90a3198.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINHAWAII REPACK, INC.857f256c-88ac-4f73-9815-c2724edf2f1e2026-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINREMEDYREPACK INC.9f944b63-9b60-437a-ba57-d14d7976bc322026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.a5ae33ad-4703-4cb2-8618-6439c906be992026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.814450ae-439e-4a5d-8c60-9b21b6f14be52025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b1a4aabb-42af-4133-8e82-0c7ec8fa79c32025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINPD-Rx Pharmaceuticals, Inc.b8defac4-9deb-433b-928e-0ef4ee0123a22025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINAdvanced Rx of Tennessee, LLCafd5cb35-4232-f8b1-e053-2a95a90a8c5b2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINAurobindo Pharma Limited529ac72c-c4a0-4001-8cf9-b94f5bf7265c2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINAsclemed USA, Inc.2e32a8aa-047b-46c6-b67b-d88a9a0a810b2024-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043
LevofloxacinLEVOFLOXACINProficient Rx LP30958610-3803-45e6-aa3c-d256decbe6e42019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201043
application number: ANDA201043

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSNbdad0b58-495d-2352-e053-2a95a90a319812
311296levofloxacin 750 MG Oral TabletSCDbdad0b58-495d-2352-e053-2a95a90a319812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0998-16729609980110 TABLET, FILM COATED in 1 BOTTLE (67296-0998-1) 2021-03-010000-00-00NoNoCurrent
67296-0998-5672960998055 TABLET, FILM COATED in 1 BOTTLE (67296-0998-5) 2021-03-010000-00-00NoNoCurrent
67296-0998-7672960998077 TABLET, FILM COATED in 1 BOTTLE (67296-0998-7) 2021-03-010000-00-00NoNoCurrent