Home NDC 33342-022-31 Levofloxacin
Product NDC 33342-022
Requested package NDC 33342-022-31
11-digit product format 333420022
Labeler code 33342
Product ID 33342-022_6e18a5b5-0bd5-4d25-a845-c9f44ce0151d
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
Marketing end 0000-00-00
Substance LEVOFLOXACIN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2024-12-31
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 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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 10 LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 3 LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 2 LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS] 2 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-022 LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 22 Legacy NDC 20230219_6ed56fa0-4813-4dc9-82c7-6dadf91f586f.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 33342-022-31 33342002231 50 TABLET, FILM COATED in 1 BLISTER PACK (33342-022-31) 2012-03-22 0000-00-00 No No Current