levofloxacin

Product NDC
63187-514
11-digit product format
631870514
Labeler code
63187
Product ID
63187-514_2fb76e4a-2c83-4764-a399-ff7811f179c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077652
Marketing category
ANDA
Marketing start
2012-11-10
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-514DDiscontinued by firm2026-09-09
excluded packagepackage63187-51463187-514-05DDiscontinued by firm2026-09-09
excluded packagepackage63187-51463187-514-07DDiscontinued by firm2026-09-09
excluded packagepackage63187-51463187-514-10DDiscontinued by firm2026-09-09
excluded packagepackage63187-51463187-514-15DDiscontinued by firm2026-09-09
excluded packagepackage63187-51463187-514-30DDiscontinued by firm2026-09-09
excluded packagepackage63187-51463187-514-60DDiscontinued by firm2026-09-09
excluded packagepackage63187-51463187-514-90DDiscontinued by firm2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-514-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-514-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-514-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-514-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-514-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-514-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-514-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-514-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-514-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-514-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-514-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-514-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-514-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-514-10f5e01cc5f278…a2eaf40c39c3…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-514-07EA - Each63187-5145340dcbd-5e32-4c30-a52c-fd3d9afd42d312015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WELEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-514LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20210114_6e77bd45-bd4b-4ec3-94cd-f6c3858aeaf8.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
LevofloxacinLLEVOFLOXACINAdvanced Rx Pharmacy of Tennessee, LLC19afbe98-484c-c980-e063-6294a90acdc62024-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077652
application number: ANDA077652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-514-05631870514055 TABLET, FILM COATED in 1 BOTTLE (63187-514-05) 2018-12-010000-00-00NoNoCurrent
63187-514-07631870514077 TABLET, FILM COATED in 1 BOTTLE (63187-514-07) 2018-12-010000-00-00NoNoCurrent
63187-514-106318705141010 TABLET, FILM COATED in 1 BOTTLE (63187-514-10) 2018-12-010000-00-00NoNoCurrent
63187-514-156318705141515 TABLET, FILM COATED in 1 BOTTLE (63187-514-15) 2018-12-010000-00-00NoNoCurrent
63187-514-306318705143030 TABLET, FILM COATED in 1 BOTTLE (63187-514-30) 2018-12-010000-00-00NoNoCurrent
63187-514-606318705146060 TABLET, FILM COATED in 1 BOTTLE (63187-514-60) 2018-12-010000-00-00NoNoCurrent
63187-514-906318705149090 TABLET, FILM COATED in 1 BOTTLE (63187-514-90) 2018-12-010000-00-00NoNoCurrent