Levofloxacin

Product NDC: 63323-355
11-digit product format: 633230355
Labeler code: 63323
Product ID: 63323-355_d2cd980c-648b-4efd-b39d-49c8e0f8f9b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOFLOXACIN
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA200674
Marketing category: ANDA
Marketing start: 2013-06-20
Substance: LEVOFLOXACIN
Active strength: 5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19
A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19
A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200674-001	AP
A200674-002	AP
A200674-003	AP

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 · 126 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
2026-08-18 06:07:40	2026-07	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200674-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200674-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200674-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2013-06-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200674-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200674-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200674-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200674-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200674-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200674-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200674-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200674-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200674-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200674-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200674-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200674-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200674-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200674-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200674-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200674-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200674-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200674-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200674-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200674-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200674-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200674-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200674-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200674-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200674-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200674-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200674-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200674-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200674-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200674-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200674-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200674-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200674-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200674-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200674-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200674-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200674-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200674-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200674-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200674-001	AP	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levofloxacin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOFLOXACIN	5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1665497	Internal RxNorm lookup
1665507	Internal RxNorm lookup
1665515	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
eb30fafa-bbb9-458f-89df-ae610fa6aa96	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	SPL version
63323-355-50	Levofloxacin	50 mL in 1 BAG	INJECTION	50	6
63323-355-50	Levofloxacin	1 in 1 POUCH	INJECTION	1	6
63323-355-60	Levofloxacin	1 in 1 POUCH	INJECTION	1	6
63323-355-60	Levofloxacin	150 mL in 1 BAG	INJECTION	150	6
63323-355-65	Levofloxacin	1 in 1 POUCH	INJECTION	1	6
63323-355-65	Levofloxacin	100 mL in 1 BAG	INJECTION	100	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-355-50	ML - Milliliter	63323-355	b7cff7d8-7481-4f6d-8bd4-930b91626a00	1	2013-08-02
63323-355-60	ML - Milliliter	63323-355	1d33c9ec-ea82-4a84-aadd-058690760e67	1	2013-08-02
63323-355-65	ML - Milliliter	63323-355	3881f723-8309-4b6d-b01f-f86395646a9e	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN INJECTION [FRESENIUS KABI USA, LLC]	3
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN INJECTION [FRESENIUS KABI USA, LLC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LEVOFLOXACIN INJECTION [FRESENIUS KABI USA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LEVOFLOXACIN INJECTION [FRESENIUS KABI USA, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-355	LEVOFLOXACIN INJECTION [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 6 package rows	20240524_eb30fafa-bbb9-458f-89df-ae610fa6aa96.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	Fresenius Kabi USA, LLC	eb30fafa-bbb9-458f-89df-ae610fa6aa96	2024-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200674 application number: ANDA200674 ndc (product): 63323-355

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	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665507	levoFLOXacin 500 MG in 100 ML Injection	PSN	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665515	levoFLOXacin 750 MG in 150 ML Injection	PSN	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665507	100 ML levofloxacin 5 MG/ML Injection	SCD	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665515	150 ML levofloxacin 5 MG/ML Injection	SCD	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665497	50 ML levofloxacin 5 MG/ML Injection	SCD	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665497	levofloxacin 250 MG per 50 ML Injection	SY	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665507	levofloxacin 500 MG per 100 ML Injection	SY	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6
1665515	levofloxacin 750 MG per 150 ML Injection	SY	eb30fafa-bbb9-458f-89df-ae610fa6aa96	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-355-50	63323035550	1 BAG in 1 POUCH (63323-355-50) / 50 mL in 1 BAG	1 bag	2013-06-20	0000-00-00	No	No	Current
63323-355-60	63323035560	1 BAG in 1 POUCH (63323-355-60) / 150 mL in 1 BAG	1 bag	2013-06-20	0000-00-00	No	No	Current
63323-355-65	63323035565	1 BAG in 1 POUCH (63323-355-65) / 100 mL in 1 BAG	1 bag	2013-06-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	Fresenius Kabi USA, LLC \| HP Halden Pharma AS	2024-05-22	HUMAN PRESCRIPTION DRUG LABEL	6