Levofloxacin

Product NDC
36000-296
11-digit product format
360000296
Labeler code
36000
Product ID
36000-296_d689d86e-6b4b-4a72-881c-ceb8196f2e2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA091397
Marketing category
ANDA
Marketing start
2013-07-01
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36000-296DDiscontinued by firm2026-10-15
excluded packagepackage36000-29636000-296-24DDiscontinued by firm2026-10-15

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 · 18 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 packagepackage36000-296-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36000-296-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36000-296-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36000-296-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36000-296-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36000-296-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36000-296-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36000-296-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36000-296-240efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08
A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08
A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERLEVOFLOXACINEQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08c2088c7a36db…
2026-10-15 13:18:302026-09A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08c2088c7a36db…
2026-10-15 13:18:302026-09A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08c2088c7a36db…
2026-09-14 22:38:342026-08A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0884e616aacf4f…
2026-09-14 22:38:342026-08A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0884e616aacf4f…
2026-08-18 06:07:402026-07A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTION2013-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A091397-002LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 500MG/100ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A091397-003LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 750MG/150ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091397-001LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 250MG/50ML (EQ 5MG/ML)INJECTABLE / INJECTIONAP2013-08-0879d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-12-28 21:50 UTC2021-12A091397-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091397-003AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091397-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091397-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091397-003AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A091397-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091397-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091397-003AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091397-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091397-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091397-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091397-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091397-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091397-003AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091397-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A091397-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A091397-003AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A091397-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091397-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091397-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091397-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091397-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091397-003AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091397-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091397-002AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091397-003AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091397-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A091397-002AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A091397-003AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091397-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A091397-002AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A091397-003AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091397-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091397-002AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091397-003AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091397-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091397-002AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091397-003AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091397-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091397-002AP1a67488948f0b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-296-24ML - Milliliter36000-296ee8983d6-6de7-4c42-9370-2b33e6dcb94a12019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36000-296-2436000029624150 mL in 1 BAG (36000-296-24) 150 ml2019-04-150000-00-00NoNoCurrent