Levofloxacin

Product NDC
43063-459
11-digit product format
430630459
Labeler code
43063
Product ID
43063-459_413846f3-6d6b-3731-e063-6394a90afd7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
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
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…

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
814450ae-439e-4a5d-8c60-9b21b6f14be5Available 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
43063-459-05Levofloxacin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED521
43063-459-07Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED721
43063-459-10Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1021
43063-459-20Levofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-459-05EA - Each43063-459a4e22098-2b4a-41da-868a-0e68449af7e312015-08-04
43063-459-07EA - Each43063-459769a015a-e7ec-4a19-bf4b-555c716f360312013-08-02
43063-459-10EA - Each43063-4590d7a3ae0-a1d6-43ac-924c-6b6825a43eca12015-08-04
43063-459-20EA - Each43063-459a2dea678-2295-44ba-bdb1-dc94b666694812016-01-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-459LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 4 package rows20240809_814450ae-439e-4a5d-8c60-9b21b6f14be5.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
ndc (product): 43063-459
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 TabletPSN814450ae-439e-4a5d-8c60-9b21b6f14be521
311296levofloxacin 750 MG Oral TabletSCD814450ae-439e-4a5d-8c60-9b21b6f14be521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-459-05430630459055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-05) 2012-09-250000-00-00NoNoCurrent
43063-459-07430630459077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-07) 2012-09-250000-00-00NoNoCurrent
43063-459-104306304591010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-10) 2012-09-250000-00-00NoNoCurrent
43063-459-204306304592020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-20) 2012-09-250000-00-00NoNoCurrent