Levofloxacin

Product NDC
17478-107
Requested package NDC
17478-107-20
11-digit product format
174780107
Labeler code
17478
Product ID
17478-107_1df0a7b7-b4af-4efa-b0b9-74d891c14f4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Akorn
Application
ANDA091644
Marketing category
ANDA
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17478-10717478-107-20IInactivated by FDA2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091644-001LEVOFLOXACINLEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20
A091644-002LEVOFLOXACINLEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091644-001AP
A091644-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAPRS2011-06-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091644-001LEVOFLOXACINEQ 500MG/20ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091644-002LEVOFLOXACINEQ 750MG/30ML (EQ 25MG/ML)INJECTABLE / INJECTIONAP2011-06-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091644-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A091644-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091644-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091644-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091644-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091644-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091644-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091644-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091644-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091644-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091644-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091644-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091644-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091644-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091644-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091644-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091644-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091644-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091644-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091644-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091644-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091644-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091644-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091644-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091644-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091644-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091644-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091644-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091644-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091644-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091644-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091644-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091644-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091644-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091644-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091644-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091644-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091644-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091644-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091644-002AP1bb7c543d1eb4…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-107-20Levofloxacin20 mL in 1 VIALINJECTION2013
17478-107-20Levofloxacin1 in 1 CARTONINJECTION113
17478-107-30Levofloxacin1 in 1 CARTONINJECTION113
17478-107-30Levofloxacin30 mL in 1 VIALINJECTION3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-107-20ML - Milliliter17478-107ba3d6855-f7d6-4db4-97b1-1e6f4515ff9812012-07-24
17478-107-30ML - Milliliter17478-10753d80233-0ff1-4648-ac4f-ff5091b67f5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN INJECTION [AKORN, INC.]5
Levofloxacin AnhydrousACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN INJECTION [AKORN, INC.]5
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN INJECTION [AKORN, INC.]5
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN INJECTION [AKORN, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-107LEVOFLOXACIN INJECTION [AKORN]13Legacy NDC, 4 package rows20220914_4438fed2-7ef5-488f-baa8-39bc65768d1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665517levoFLOXacin 500 MG in 20 ML InjectionPSN4438fed2-7ef5-488f-baa8-39bc65768d1d13
1665519levoFLOXacin 750 MG in 30 ML InjectionPSN4438fed2-7ef5-488f-baa8-39bc65768d1d13
166551720 ML levofloxacin 25 MG/ML InjectionSCD4438fed2-7ef5-488f-baa8-39bc65768d1d13
166551930 ML levofloxacin 25 MG/ML InjectionSCD4438fed2-7ef5-488f-baa8-39bc65768d1d13
1665517levofloxacin 500 MG per 20 ML InjectionSY4438fed2-7ef5-488f-baa8-39bc65768d1d13
1665519levofloxacin 750 MG per 30 ML InjectionSY4438fed2-7ef5-488f-baa8-39bc65768d1d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-107-20174780107201 VIAL in 1 CARTON (17478-107-20) > 20 mL in 1 VIAL1 vial2011-07-010000-00-00NoNoCurrent