FDA.reportPublic FDA data

Levofloxacin

Product NDC
54288-140
11-digit product format
542880140
Labeler code
54288
Product ID
54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
BPI LABS LLC
Application
ANDA205600
Marketing category
ANDA
Marketing start
2020-07-13
Substance
LEVOFLOXACIN
Active strength
15 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205600-001LEVOFLOXACINLEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205600-001LEVOFLOXACIN1.5%SOLUTION/DROPS / OPHTHALMIC2019-02-27e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN15 mg/mL

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
545118Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10Available 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
54288-140-01Levofloxacin5 mL in 1 CARTONSOLUTION/ DROPS58
54288-140-01Levofloxacin1 in 1 CARTONSOLUTION/ DROPS18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-140-01ML - Milliliter54288-1408cf2194a-997a-41b0-8d56-77e5ca892c4e12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-140LEVOFLOXACIN SOLUTION/ DROPS [BPI LABS LLC]7Current NDC, Legacy NDC, 2 package rows20250213_b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevofloxacinLEVOFLOXACINBPI LABS LLCb6d9740b-2f9d-4f1c-bc9b-4c2150b22f102025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205600
application number: ANDA205600
ndc (product): 54288-140

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545118levoFLOXacin 1.5 % Ophthalmic SolutionPSNb6d9740b-2f9d-4f1c-bc9b-4c2150b22f108
545118levofloxacin 15 MG/ML Ophthalmic SolutionSCDb6d9740b-2f9d-4f1c-bc9b-4c2150b22f108
545118levofloxacin 1.5 % Ophthalmic SolutionSYb6d9740b-2f9d-4f1c-bc9b-4c2150b22f108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-140-01542880140011 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTON1 carton2020-07-130000-00-00NoNoCurrent