Home NDC 33342-531 Levofloxacin
Product NDC 33342-531
11-digit product format 333420531
Labeler code 33342
Product ID 33342-531_fc165a6d-24b0-4753-a7ac-94a134dca0d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA200839
Marketing category ANDA
Marketing start 2012-03-22
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 A200839-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 A200839-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 A200839-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22
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 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200839-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2012-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200839-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2012-03-22 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 2026-12-31 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 33342-531-08 Levofloxacin 50 in 1 BOTTLE TABLET, FILM COATED 50 1 33342-531-11 Levofloxacin 100 in 1 BOTTLE TABLET, FILM COATED 100 1 33342-531-12 Levofloxacin 100 in 1 BLISTER PACK TABLET, FILM COATED 100 1 33342-531-31 Levofloxacin 50 in 1 BLISTER PACK TABLET, FILM COATED 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-531 LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, Legacy NDC, 4 package rows 20230110_fc165a6d-24b0-4753-a7ac-94a134dca0d3.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 · 2 matching rows.
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 33342-531-08 33342053108 50 TABLET, FILM COATED in 1 BOTTLE (33342-531-08) 2012-03-22 0000-00-00 No No Current 33342-531-11 33342053111 100 TABLET, FILM COATED in 1 BOTTLE (33342-531-11) 2012-03-22 0000-00-00 No No Current 33342-531-12 33342053112 100 TABLET, FILM COATED in 1 BLISTER PACK (33342-531-12) 2012-03-22 0000-00-00 No No Current 33342-531-31 33342053131 50 TABLET, FILM COATED in 1 BLISTER PACK (33342-531-31) 2012-03-22 0000-00-00 No No Current