Home NDC 0527-1948 Levofloxacin
Product NDC 0527-1948
11-digit product format 005271948
Labeler code 0527
Product ID 0527-1948_01e976a4-eb3a-4d1a-a384-46222c20afc5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA205222
Marketing category ANDA
Marketing start 2018-05-25
Substance LEVOFLOXACIN
Active strength 25 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 42 .
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 A205222-001 LEVOFLOXACIN LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205222-001 AA
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 · 42 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 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205222-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA 2018-05-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 25 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 477391 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 0527-1948-66 Levofloxacin 1 in 1 CARTON SOLUTION 1 28 0527-1948-66 Levofloxacin 100 mL in 1 BOTTLE, PLASTIC SOLUTION 100 28 0527-1948-68 Levofloxacin 200 mL in 1 BOTTLE, PLASTIC SOLUTION 200 28 0527-1948-68 Levofloxacin 1 in 1 CARTON SOLUTION 1 28 0527-1948-70 Levofloxacin 1 in 1 CARTON SOLUTION 1 28 0527-1948-70 Levofloxacin 480 mL in 1 BOTTLE, PLASTIC SOLUTION 480 28
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1948 LEVOFLOXACIN SOLUTION [LANNETT COMPANY, INC.] 27 Current NDC, Legacy NDC, 6 package rows 20240629_362fb864-3afb-4841-a7c4-b64b1346aba0.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0527-1948-66 00527194866 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTIC 2018-05-25 0000-00-00 No No Current 0527-1948-68 00527194868 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTIC 2018-05-25 0000-00-00 No No Current 0527-1948-70 00527194870 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-70) / 480 mL in 1 BOTTLE, PLASTIC 2018-05-25 0000-00-00 No No Current