Home NDC 62135-655 Levofloxacin
Product NDC 62135-655
11-digit product format 621350655
Labeler code 62135
Product ID 62135-655_10182104-3b25-869e-e063-6394a90ab116
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA076890
Marketing category ANDA
Marketing start 2012-03-30
Substance LEVOFLOXACIN
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Levofloxacin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOFLOXACIN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6GNT3Y5LMF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199884 Internal RxNorm lookup 199885 Internal RxNorm lookup 311296 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-655-14 Levofloxacin 14 in 1 BOTTLE TABLET 14 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-655 LEVOFLOXACIN TABLET [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20240130_5c6c117c-9d91-48f4-9aaa-ee70b99218c2.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-655-14 62135065514 14 TABLET in 1 BOTTLE (62135-655-14) 14 tablet 2024-01-19 No No Current