Home NDC 50090-4797-1 Levofloxacin
Product NDC 50090-4797
Requested package NDC 50090-4797-1
11-digit product format 500904797
Labeler code 50090
Product ID 50090-4797_1c1a779e-f37c-4f24-a805-672831c56c29
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA200839
Marketing category ANDA
Marketing start 2012-03-22
Marketing end 0000-00-00
Substance LEVOFLOXACIN
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-4797 50090-4797-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-4797 50090-4797-1 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200839-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 A200839-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 A200839-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 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 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4797 LEVOFLOXACIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 7 Legacy NDC 20240731_c3d845ff-b1e0-4577-bba4-830986529573.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-4797-1 50090479701 10 TABLET, FILM COATED in 1 BOTTLE (50090-4797-1) 2019-12-13 0000-00-00 No No Current