Home NDC 69097-287-81 Levofloxacin
Product NDC 69097-287
Requested package NDC 69097-287-81
11-digit product format 690970287
Labeler code 69097
Product ID 69097-287_4289ae91-dfde-435c-847b-1815c0693431
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET
Route ORAL
Labeler Cipla USA Inc.
Application ANDA076890
Marketing category ANDA
Marketing start 2012-03-30
Marketing end 0000-00-00
Substance LEVOFLOXACIN
Active strength 750 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 A076890-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 A076890-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 A076890-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30
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 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076890-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076890-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076890-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# 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 69097-287-81 69097028781 20 TABLET in 1 BOTTLE (69097-287-81) 20 tablet 2012-03-30 0000-00-00 No No Current