Home NDC 42571-168 LEVOFLOXACIN
Product NDC 42571-168
11-digit product format 425710168
Labeler code 42571
Product ID 42571-168_833c5e2e-8b64-3b8f-e053-2a91aa0ab453
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Micro Labs Limited
Application ANDA205600
Marketing category ANDA
Marketing start 2019-04-16
Substance LEVOFLOXACIN
Active strength 15 mg/mL
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205600-001 LEVOFLOXACIN LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205600-001 LEVOFLOXACIN 1.5% SOLUTION/DROPS / OPHTHALMIC 2019-02-27 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base LEVOFLOXACIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVOFLOXACIN 15 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545118 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 42571-168-25 LEVOFLOXACIN 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 6 42571-168-25 LEVOFLOXACIN 1 in 1 CARTON SOLUTION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-168 LEVOFLOXACIN (LEVOFLOXACIN) SOLUTION/ DROPS [MICRO LABS LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20190416_c0417827-3c49-4dbd-97a8-3e2bb509d157.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 Units Marketing start Marketing end Sample Exclude flag Status 42571-168-25 42571016825 1 BOTTLE in 1 CARTON (42571-168-25) / 5 mL in 1 BOTTLE 1 bottle 2019-04-16 0000-00-00 No No Current