Home NDC 21695-024 Levofloxacin
Product NDC 21695-024
11-digit product format 216950024
Labeler code 21695
Product ID 21695-024_f82ee9e3-5119-4be0-883c-5831386baef6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA076361
Marketing category ANDA
Marketing start 2011-06-20
Marketing end 0000-00-00
Substance LEVOFLOXACIN
Active strength 250 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 2026-09-14 22:38:34 2026-08 A076361-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076361-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076361-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 21695-024-03 Levofloxacin 03 in 1 BOTTLE TABLET, FILM COATED 03 3 21695-024-10 Levofloxacin 10 in 1 BOTTLE TABLET, FILM COATED 10 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 LEVOFLOXACIN ACTIVE MOIETY 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-024 LEVOFLOXACIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 3 Legacy NDC, 2 package rows 20120511_312e65cb-897f-4c24-b17b-be7e8ce469bb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-024-03 21695002403 03 in 1 BOTTLE Historical 21695-024-10 21695002410 10 in 1 BOTTLE Historical