levofloxacin

Product NDC
65841-693
11-digit product format
658410693
Labeler code
65841
Product ID
65841-693_5aeae448-e53f-4954-9dd9-2bcc3dd791d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077652
Marketing category
ANDA
Marketing start
2012-11-10
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
ffa121b8-388f-4d7b-af48-d4aa8d9b5961Available 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
65841-693-01levofloxacin100 in 1 BOTTLETABLET, FILM COATED10011
65841-693-05levofloxacin500 in 1 BOTTLETABLET, FILM COATED50011
65841-693-06levofloxacin30 in 1 BOTTLETABLET, FILM COATED3011
65841-693-18levofloxacin50 in 1 BOTTLETABLET, FILM COATED5011
65841-693-92levofloxacin20 in 1 BOTTLETABLET, FILM COATED2011

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-693LEVOFLOXACIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 5 package rows20240821_ffa121b8-388f-4d7b-af48-d4aa8d9b5961.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
ndc (product): 65841-693
levofloxacinLEVOFLOXACINViona Pharmaceuticals Inc0948bff7-efc6-4f0e-a9dd-adca5bdc7fc22024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652
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
199884levoFLOXacin 250 MG Oral TabletPSNffa121b8-388f-4d7b-af48-d4aa8d9b596111
199885levoFLOXacin 500 MG Oral TabletPSNffa121b8-388f-4d7b-af48-d4aa8d9b596111
311296levoFLOXacin 750 MG Oral TabletPSNffa121b8-388f-4d7b-af48-d4aa8d9b596111
199884levofloxacin 250 MG Oral TabletSCDffa121b8-388f-4d7b-af48-d4aa8d9b596111
199885levofloxacin 500 MG Oral TabletSCDffa121b8-388f-4d7b-af48-d4aa8d9b596111
311296levofloxacin 750 MG Oral TabletSCDffa121b8-388f-4d7b-af48-d4aa8d9b596111
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYffa121b8-388f-4d7b-af48-d4aa8d9b596111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-693-0165841069301100 TABLET, FILM COATED in 1 BOTTLE (65841-693-01) 2012-11-100000-00-00NoNoCurrent
65841-693-0565841069305500 TABLET, FILM COATED in 1 BOTTLE (65841-693-05) 2012-11-100000-00-00NoNoCurrent
65841-693-066584106930630 TABLET, FILM COATED in 1 BOTTLE (65841-693-06) 2022-01-100000-00-00NoNoCurrent
65841-693-186584106931850 TABLET, FILM COATED in 1 BOTTLE (65841-693-18) 2012-11-100000-00-00NoNoCurrent
65841-693-926584106939220 TABLET, FILM COATED in 1 BOTTLE (65841-693-92) 2022-01-100000-00-00NoNoCurrent