Levofloxacin

Product NDC
63187-833
11-digit product format
631870833
Labeler code
63187
Product ID
63187-833_e5c99469-b1e5-4f86-b4fa-7fcb4eac8f46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202801
Marketing category
ANDA
Marketing start
2015-01-09
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2026-12-31

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
95149cfb-1a71-42b7-b50d-9a2e94334339Available 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
63187-833-05Levofloxacin05 in 1 BOTTLETABLET, FILM COATED056
63187-833-07Levofloxacin07 in 1 BOTTLETABLET, FILM COATED076
63187-833-10Levofloxacin10 in 1 BOTTLETABLET, FILM COATED106
63187-833-30Levofloxacin30 in 1 BOTTLETABLET, FILM COATED306
63187-833-60Levofloxacin60 in 1 BOTTLETABLET, FILM COATED606
63187-833-90Levofloxacin90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-833-05EA - Each63187-83354479980-5918-40aa-80b0-79e56472be7212018-12-13
63187-833-07EA - Each63187-833b0768ea9-56a1-414b-8d58-988bc4f5f5c412017-10-13
63187-833-10EA - Each63187-833e88d0a65-e3ec-482a-90b8-338db04f21ac12017-06-15
63187-833-30EA - Each63187-833c0e08955-9fa7-418c-aa77-b8310b3ba07012021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-833LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20220930_95149cfb-1a71-42b7-b50d-9a2e94334339.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
311296levoFLOXacin 750 MG Oral TabletPSN95149cfb-1a71-42b7-b50d-9a2e943343396
311296levofloxacin 750 MG Oral TabletSCD95149cfb-1a71-42b7-b50d-9a2e943343396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-833-05631870833055 TABLET, FILM COATED in 1 BOTTLE (63187-833-05) 2017-05-010000-00-00NoNoCurrent
63187-833-07631870833077 TABLET, FILM COATED in 1 BOTTLE (63187-833-07) 2017-05-010000-00-00NoNoCurrent
63187-833-106318708331010 TABLET, FILM COATED in 1 BOTTLE (63187-833-10) 2017-05-010000-00-00NoNoCurrent
63187-833-306318708333030 TABLET, FILM COATED in 1 BOTTLE (63187-833-30) 2017-05-010000-00-00NoNoCurrent
63187-833-606318708336060 TABLET, FILM COATED in 1 BOTTLE (63187-833-60) 2017-05-010000-00-00NoNoCurrent
63187-833-906318708339090 TABLET, FILM COATED in 1 BOTTLE (63187-833-90) 2017-05-010000-00-00NoNoCurrent