Home NDC 55150-156-20 Levofloxacin
Product NDC 55150-156
Requested package NDC 55150-156-20
11-digit product format 551500156
Labeler code 55150
Product ID 55150-156_2a91fee4-6952-42e2-8326-c2d4233d11d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA202328
Marketing category ANDA
Marketing start 2013-01-24
Substance LEVOFLOXACIN
Active strength 500 mg/20mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202328-001 LEVOFLOXACIN LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 A202328-002 LEVOFLOXACIN LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24
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 3 · 86 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 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION 2013-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202328-001 LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202328-002 LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) INJECTABLE / INJECTION AP RS 2013-01-24 74a2ff9319b5…
Observed Orange Book normalized TE history# 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 500 mg/20mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665517 Internal RxNorm lookup 1665519 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 55150-156-20 Levofloxacin 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 13 55150-156-20 Levofloxacin 20 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION, CONCENTRATE 20 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LEVOFLOXACIN ACTIVE INGREDIENT 6GNT3Y5LMF LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] 6 LEVOFLOXACIN ANHYDROUS ACTIVE MOIETY RIX4E89Y14 LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] 6 WATER INACTIVE INGREDIENT 059QF0KO0R LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-156 LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [EUGIA US LLC] 13 Current NDC, Legacy NDC, 2 package rows 20240622_4d400bf9-988f-42ec-93f1-e71a93a324b2.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 Marketing start Marketing end Sample Exclude flag Status 55150-156-20 55150015620 1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) / 20 mL in 1 VIAL, SINGLE-USE 2013-01-24 0000-00-00 No No Current