Home NDC 45865-758 Levofloxacin
Product NDC 45865-758
11-digit product format 458650758
Labeler code 45865
Product ID 45865-758_9ab3a76c-4ca4-76d4-e053-2a95a90a0a64
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Medsource Pharmaceuticals
Application ANDA076361
Marketing category ANDA
Marketing start 2011-06-20
Marketing end 0000-00-00
Substance LEVOFLOXACIN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45865-758-07 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45865-758-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45865-758-14 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-758-07 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-758-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-758-14 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-758-07 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-758-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-758-14 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-758-07 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-758-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-758-14 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-758-07 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-758-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-758-14 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-758-07 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-758-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-758-14 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-758-14 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-758-07 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-758-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-758-14 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-758-07 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-758-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-758-14 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-758-07 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-758-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A076361-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 A076361-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 A076361-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20
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 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45865-758-07 Levofloxacin 7 in 1 BOTTLE TABLET, FILM COATED 7 2 45865-758-14 Levofloxacin 14 in 1 BOTTLE TABLET, FILM COATED 14 2 45865-758-30 Levofloxacin 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-758 LEVOFLOXACIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 Legacy NDC, 3 package rows 20191228_205d5ba3-4138-0b27-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45865-758-07 45865075807 7 TABLET, FILM COATED in 1 BOTTLE (45865-758-07) 2015-09-21 0000-00-00 No No Current 45865-758-14 45865075814 14 TABLET, FILM COATED in 1 BOTTLE (45865-758-14) 2015-09-21 0000-00-00 No No Current 45865-758-30 45865075830 30 TABLET, FILM COATED in 1 BOTTLE (45865-758-30) 2011-06-20 0000-00-00 No No Current