Home NDC 68084-482 Levofloxacin
Product NDC 68084-482
11-digit product format 680840482
Labeler code 68084
Product ID 68084-482_815354e0-9c35-6a55-e053-2a91aa0ae3c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA078424
Marketing category ANDA
Marketing start 2011-06-21
Marketing end 2019-08-31
Substance LEVOFLOXACIN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68084-482-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68084-482-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68084-482-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68084-482-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68084-482-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68084-482-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68084-482-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68084-482-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68084-482-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68084-482-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68084-482-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68084-482-01 557ba5c1ecfa…9c80585c8c6e…
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 A078424-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL 2011-06-20 A078424-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL 2011-06-20 A078424-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL 2011-06-20
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 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL 2011-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL 2011-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL 2011-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Levofloxacin LEVOFLOXACIN Lupin Pharmaceuticals, Inc. 4be13bd5-0c39-43c3-9232-b1226ccd4dbc 2024-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078424 application number: ANDA078424