levofloxacin

Product NDC
72578-100
11-digit product format
725780100
Labeler code
72578
Product ID
72578-100_6295ff00-86a9-454c-987b-a1fe1c4386e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA077652
Marketing category
ANDA
Marketing start
2022-01-10
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 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
A077652-001LEVOFLOXACINLEVOFLOXACIN250MGTABLET / ORALAB2012-09-07
A077652-002LEVOFLOXACINLEVOFLOXACIN500MGTABLET / ORALAB2012-09-07
A077652-003LEVOFLOXACINLEVOFLOXACIN750MGTABLET / ORALAB2012-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077652-001AB
A077652-002AB
A077652-003AB

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 06:07:402026-07A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-002LEVOFLOXACIN500MGTABLET / ORALAB2012-09-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-003LEVOFLOXACIN750MGTABLET / ORALAB2012-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077652-001LEVOFLOXACIN250MGTABLET / ORALAB2012-09-071e350fbaab3a…

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 06:07:402026-07A077652-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077652-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077652-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077652-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077652-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077652-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077652-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077652-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077652-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077652-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077652-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077652-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077652-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077652-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077652-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077652-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077652-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077652-001AB11e350fbaab3a…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199884Internal RxNorm lookup
199885Internal RxNorm lookup
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
0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72578-100-01levofloxacin100 in 1 BOTTLETABLET, FILM COATED1003
72578-100-05levofloxacin500 in 1 BOTTLETABLET, FILM COATED5003
72578-100-06levofloxacin30 in 1 BOTTLETABLET, FILM COATED303
72578-100-18levofloxacin50 in 1 BOTTLETABLET, FILM COATED503
72578-100-92levofloxacin20 in 1 BOTTLETABLET, FILM COATED203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-100-06EA - Each72578-100fc8ee7e9-83a9-4525-bdda-267d1f063a1b12022-05-04
72578-100-92EA - Each72578-100d2405204-09a3-4428-aa4e-c92ed4ecc81812022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-100LEVOFLOXACIN TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 5 package rows20240629_0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levofloxacinLEVOFLOXACINBryant Ranch Prepackb9dc8bf3-97d9-4d1c-9a68-3ae553acdada2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug5261da15-1b6c-fbe2-e063-6394a90ad85e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug44f31105-5fc9-43d4-e063-6294a90a510f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINREMEDYREPACK INC.264a3f71-f23e-45e3-926a-421bcccf4e3d2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc.7a12135e-cbad-4fe1-98f7-53c41d1f2a212026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINRedpharm Drug301ecffc-ecaf-01de-e063-6294a90a61b32025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackcbd5153f-fada-4682-b858-dc3b6e3173cc2025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINCoupler LLC2cee61b7-be51-0fe5-e063-6294a90af9e32025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINPreferred Pharmaceuticals Inc067e260c-dc47-4957-a9ff-5a79f17b4ca02025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINBryant Ranch Prepackb7a614b0-f604-48e1-9919-21da8f939d932024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINZydus Lifesciences Limitedffa121b8-388f-4d7b-af48-d4aa8d9b59612024-08-16Exact identifier
application applno (ANDA): 077652
application number: ANDA077652
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
ndc (product): 72578-100
LevofloxacinLLEVOFLOXACINAdvanced Rx Pharmacy of Tennessee, LLC19afbe98-484c-c980-e063-6294a90acdc62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSNcbd5153f-fada-4682-b858-dc3b6e3173cc102
311296levofloxacin 750 MG Oral TabletSCDcbd5153f-fada-4682-b858-dc3b6e3173cc102
199884levoFLOXacin 250 MG Oral TabletPSN0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199885levoFLOXacin 500 MG Oral TabletPSN0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
311296levoFLOXacin 750 MG Oral TabletPSN0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199884levofloxacin 250 MG Oral TabletSCD0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199885levofloxacin 500 MG Oral TabletSCD0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
311296levofloxacin 750 MG Oral TabletSCD0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
311296levoFLOXacin 750 MG Oral TabletPSN067e260c-dc47-4957-a9ff-5a79f17b4ca02
311296levoFLOXacin 750 MG Oral TabletPSN44f31105-5fc9-43d4-e063-6294a90a510f2
311296levofloxacin 750 MG Oral TabletSCD067e260c-dc47-4957-a9ff-5a79f17b4ca02
311296levofloxacin 750 MG Oral TabletSCD44f31105-5fc9-43d4-e063-6294a90a510f2
311296levoFLOXacin 750 MG Oral TabletPSN19afbe98-484c-c980-e063-6294a90acdc61
311296levofloxacin 750 MG Oral TabletSCD19afbe98-484c-c980-e063-6294a90acdc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72578-100-0172578010001100 TABLET, FILM COATED in 1 BOTTLE (72578-100-01) 2022-01-100000-00-00YesNoCurrent
72578-100-0572578010005500 TABLET, FILM COATED in 1 BOTTLE (72578-100-05) 2022-01-100000-00-00YesNoCurrent
72578-100-067257801000630 TABLET, FILM COATED in 1 BOTTLE (72578-100-06) 2022-01-100000-00-00YesNoCurrent
72578-100-187257801001850 TABLET, FILM COATED in 1 BOTTLE (72578-100-18) 2022-01-100000-00-00YesNoCurrent
72578-100-927257801009220 TABLET, FILM COATED in 1 BOTTLE (72578-100-92) 2022-01-100000-00-00YesNoCurrent