Levofloxacin

Product NDC
68788-8340
Requested package NDC
68788-8340-2
11-digit product format
687888340
Labeler code
68788
Product ID
68788-8340_e173cefa-937a-47a7-8af7-d938e10d6d38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202801
Marketing category
ANDA
Marketing start
2023-02-02
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-0884e616aacf4f…
2026-09-14 22:38:342026-08A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-0884e616aacf4f…
2026-09-14 22:38:342026-08A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-0884e616aacf4f…
2026-08-18 06:07:402026-07A202801-001LEVOFLOXACIN250MGTABLET / ORALAB2015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-002LEVOFLOXACIN500MGTABLET / ORALAB2015-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-003LEVOFLOXACIN750MGTABLET / ORALAB2015-01-08caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202801-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202801-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202801-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202801-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202801-003AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6GNT3Y5LMFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311296Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a8676a9-247f-4fdb-b644-e9785d98771fAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8340-1Levofloxacin10 in 1 BOTTLETABLET, FILM COATED104
68788-8340-2Levofloxacin20 in 1 BOTTLETABLET, FILM COATED204
68788-8340-4Levofloxacin14 in 1 BOTTLETABLET, FILM COATED144
68788-8340-7Levofloxacin7 in 1 BOTTLETABLET, FILM COATED74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8340-1EA - Each68788-83409086c813-e6ce-401a-8b38-0e4e9af0011f12023-03-13
68788-8340-2EA - Each68788-83407c24687c-8a70-493a-9039-cb78a4bac60b12023-03-13
68788-8340-4EA - Each68788-8340e25059b0-7fbf-42d4-bc2f-83518bcf687c12023-03-13
68788-8340-7EA - Each68788-834043ca7464-d216-4719-97e7-c66aef0bad5812023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8340LEVOFLOXACIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20240614_2a8676a9-247f-4fdb-b644-e9785d98771f.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
ndc (package): 68788-8340-2
ndc (product): 68788-8340
ndc11 (package): 68788834002
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
311296levoFLOXacin 750 MG Oral TabletPSN2a8676a9-247f-4fdb-b644-e9785d98771f4
311296levofloxacin 750 MG Oral TabletSCD2a8676a9-247f-4fdb-b644-e9785d98771f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8340-26878883400220 TABLET, FILM COATED in 1 BOTTLE (68788-8340-2) 2023-02-02NoNoCurrent