Home NDC 68180-242 Levofloxacin
Product NDC 68180-242
11-digit product format 681800242
Labeler code 68180
Product ID 68180-242_04b864a6-b2f7-4e3d-aa12-32a501054b9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA078424
Marketing category ANDA
Marketing start 2011-06-20
Substance LEVOFLOXACIN
Active strength 750 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078424-001 LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET / ORAL 2011-06-20 A078424-002 LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET / ORAL 2011-06-20 A078424-003 LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET / ORAL 2011-06-20
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 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL 2011-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL 2011-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL 2011-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078424-002 LEVOFLOXACIN 500MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078424-003 LEVOFLOXACIN 750MG TABLET / ORAL AB 2011-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078424-001 LEVOFLOXACIN 250MG TABLET / ORAL AB 2011-06-20 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 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 750 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 68180-242-01 Levofloxacin 100 in 1 BOTTLE TABLET, FILM COATED 100 25 68180-242-02 Levofloxacin 500 in 1 BOTTLE TABLET, FILM COATED 500 25 68180-242-11 Levofloxacin 10 in 1 BLISTER PACK TABLET, FILM COATED 10 25 68180-242-20 Levofloxacin 20 in 1 BOTTLE TABLET, FILM COATED 20 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 SHELLAC INACTIVE INGREDIENT 46N107B71O LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 8 LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEVOFLOXACIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-242 LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 25 Current NDC, Legacy NDC, 4 package rows 20240716_4be13bd5-0c39-43c3-9232-b1226ccd4dbc.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 Marketing end Sample Exclude flag Status 68180-242-01 68180024201 100 TABLET, FILM COATED in 1 BOTTLE (68180-242-01) 2011-06-20 0000-00-00 No No Current 68180-242-02 68180024202 500 TABLET, FILM COATED in 1 BOTTLE (68180-242-02) 2011-06-20 0000-00-00 No No Current 68180-242-11 68180024211 10 in 1 BLISTER PACK Historical 68180-242-13 68180024213 10 BLISTER PACK in 1 CARTON (68180-242-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-242-11) 10 blister pack 2011-06-20 0000-00-00 No No Current 68180-242-20 68180024220 20 TABLET, FILM COATED in 1 BOTTLE (68180-242-20) 2011-06-20 0000-00-00 No No Current