Levofloxacin

Product NDC: 36000-046
Requested package NDC: 36000-046-24
11-digit product format: 360000046
Labeler code: 36000
Product ID: 36000-046_44e9c8ac-2a99-4913-98d0-594e0eb98ca5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levofloxacin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: ANDA091397
Marketing category: ANDA
Marketing start: 2013-07-01
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36000-046	36000-046-24	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	2013-08-08
A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	2013-08-08
A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	2013-08-08

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION		2013-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-08-08	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091397-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091397-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091397-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091397-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091397-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091397-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091397-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091397-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091397-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091397-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091397-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091397-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091397-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091397-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091397-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091397-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091397-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091397-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091397-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091397-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091397-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091397-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091397-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091397-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091397-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091397-001	AP	1	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
36000-046-24	Levofloxacin	50 mL in 1 BAG	INJECTION, SOLUTION	50		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36000-046-24	ML - Milliliter	36000-046	a29dd5b2-368e-43bc-ae43-8829e05b95ab	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.]	9
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.]	9
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.]	9
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.]	9
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LEVOFLOXACIN INJECTION, SOLUTION [CLARIS LIFESCIENCES INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36000-046	LEVOFLOXACIN INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	26	Legacy NDC, 1 package rows	20241101_70c87464-1806-480a-8ebd-3f02987ff436.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	Baxter Healthcare Corporation	70c87464-1806-480a-8ebd-3f02987ff436	2019-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 36000-046-24 ndc (product): 36000-046 ndc11 (package): 36000004624

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
1665497	levoFLOXacin 250 MG in 50 ML Injection	PSN	70c87464-1806-480a-8ebd-3f02987ff436	27
1665507	levoFLOXacin 500 MG in 100 ML Injection	PSN	70c87464-1806-480a-8ebd-3f02987ff436	27
1665517	levoFLOXacin 500 MG in 20 ML Injection	PSN	70c87464-1806-480a-8ebd-3f02987ff436	27
1665515	levoFLOXacin 750 MG in 150 ML Injection	PSN	70c87464-1806-480a-8ebd-3f02987ff436	27
1665507	100 ML levofloxacin 5 MG/ML Injection	SCD	70c87464-1806-480a-8ebd-3f02987ff436	27
1665515	150 ML levofloxacin 5 MG/ML Injection	SCD	70c87464-1806-480a-8ebd-3f02987ff436	27
1665517	20 ML levofloxacin 25 MG/ML Injection	SCD	70c87464-1806-480a-8ebd-3f02987ff436	27
1665497	50 ML levofloxacin 5 MG/ML Injection	SCD	70c87464-1806-480a-8ebd-3f02987ff436	27
1665497	levofloxacin 250 MG per 50 ML Injection	SY	70c87464-1806-480a-8ebd-3f02987ff436	27
1665507	levofloxacin 500 MG per 100 ML Injection	SY	70c87464-1806-480a-8ebd-3f02987ff436	27
1665517	levofloxacin 500 MG per 20 ML Injection	SY	70c87464-1806-480a-8ebd-3f02987ff436	27
1665515	levofloxacin 750 MG per 150 ML Injection	SY	70c87464-1806-480a-8ebd-3f02987ff436	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36000-046-24	36000004624	50 mL in 1 BAG (36000-046-24)	50 ml	2013-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	Baxter Healthcare Corporation \| BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED	2019-03-22	HUMAN PRESCRIPTION DRUG LABEL	27