Levofloxacin

Product NDC: 55150-156
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 1.

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 · 82 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	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…`
2022-03-09 01:35 UTC	2022-03	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202328-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202328-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2013-01-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202328-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202328-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202328-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202328-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202328-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202328-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202328-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202328-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202328-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202328-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202328-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202328-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202328-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202328-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202328-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202328-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202328-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202328-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202328-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202328-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202328-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202328-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202328-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202328-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202328-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202328-002	AP	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202328-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202328-002	AP	1	`cb3db0bc1861…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4d400bf9-988f-42ec-93f1-e71a93a324b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3	Product name	2	20210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90c	Product name	4	20200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d	Product name	1	20190618
aea4a616-4dfe-45f6-94bb-8b9063056ceb	Product name	6	20190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1	Product name	1	20180821
5a6c788d-375b-4565-a8ae-67c179a30c93	Product name	1	20180212

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-156-20	ML - Milliliter	55150-156	3f85dd6d-61ec-45ee-bb3a-9a944397970e	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	Eugia US LLC	4d400bf9-988f-42ec-93f1-e71a93a324b2	2024-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202328 application number: ANDA202328 ndc (product): 55150-156

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6GNT3Y5LMF	LEVOFLOXACIN	138199-71-0	LEVOFLOXACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1665517	levoFLOXacin 500 MG in 20 ML Injection	PSN	4d400bf9-988f-42ec-93f1-e71a93a324b2	13
1665519	levoFLOXacin 750 MG in 30 ML Injection	PSN	4d400bf9-988f-42ec-93f1-e71a93a324b2	13
1665517	20 ML levofloxacin 25 MG/ML Injection	SCD	4d400bf9-988f-42ec-93f1-e71a93a324b2	13
1665519	30 ML levofloxacin 25 MG/ML Injection	SCD	4d400bf9-988f-42ec-93f1-e71a93a324b2	13
1665517	levofloxacin 500 MG per 20 ML Injection	SY	4d400bf9-988f-42ec-93f1-e71a93a324b2	13
1665519	levofloxacin 750 MG per 30 ML Injection	SY	4d400bf9-988f-42ec-93f1-e71a93a324b2	13

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	Eugia US LLC \| Apitoria Pharma Private Limited \| EUGIA PHARMA SPECIALITIES LIMITED	2024-06-17	Human Prescription Drug Label	13