Home NDC 70954-852-30 Levofloxacin
Product NDC 70954-852
Requested package NDC 70954-852-30
11-digit product format 709540852
Labeler code 70954
Product ID 70954-852_b548d9b8-70c9-41d4-8103-41568d50f561
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA091678
Marketing category ANDA
Marketing start 2024-03-26
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 43 .
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 A091678-001 LEVOFLOXACIN LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091678-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091678-001 LEVOFLOXACIN 250MG/10ML SOLUTION / ORAL AA RS 2011-06-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Levofloxacin
Listing expiration 2026-12-31 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 70954-852-10 Levofloxacin 100 mL in 1 BOTTLE SOLUTION 100 2 70954-852-20 Levofloxacin 200 mL in 1 BOTTLE SOLUTION 200 2 70954-852-30 Levofloxacin 480 mL in 1 BOTTLE SOLUTION 480 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-852 LEVOFLOXACIN SOLUTION [ANI PHARMACEUTICALS, INC.] 2 Current NDC, 3 package rows 20240625_a894e40b-77e4-439b-b0f8-9a5cc7a1dd90.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 Sample Exclude flag Status 70954-852-30 70954085230 480 mL in 1 BOTTLE (70954-852-30) 480 ml 2024-03-26 No No Current