Home NDC 36000-045-01 Levofloxacin
Product NDC 36000-045
Requested package NDC 36000-045-01
11-digit product format 360000045
Labeler code 36000
Product ID 36000-045_3cbc7b81-fabf-4666-951c-76f19e4f3222
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levofloxacin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA091436
Marketing category ANDA
Marketing start 2013-07-01
Substance LEVOFLOXACIN
Active strength 25 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 36000-045 36000-045-01 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 36000-045 36000-045-01 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091436-001 LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091436-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP 2013-06-05 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Levofloxacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOFLOXACIN 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6GNT3Y5LMF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665497 Internal RxNorm lookup 1665507 Internal RxNorm lookup 1665515 Internal RxNorm lookup 1665517 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36000-045-01 Levofloxacin 20 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 20 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36000-045 LEVOFLOXACIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 26 Current NDC, Legacy NDC, 1 package rows 20241101_70c87464-1806-480a-8ebd-3f02987ff436.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36000-045-01 36000004501 20 mL in 1 VIAL, SINGLE-USE (36000-045-01) 20 ml 2013-07-01 0000-00-00 No No Current