Levofloxacin

Product NDC: 0143-9721
11-digit product format: 001439721
Labeler code: 0143
Product ID: 0143-9721_27201c72-46ca-4507-8333-00e8ec582ba0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA091375
Marketing category: ANDA
Marketing start: 2011-09-16
Substance: LEVOFLOXACIN
Active strength: 500 mg/100mL
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
A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16
A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16
A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	LEVOFLOXACIN	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091375-001	AP
A091375-002	AP
A091375-003	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	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091375-002	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 500MG/100ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091375-003	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 750MG/150ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091375-001	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 250MG/50ML (EQ 5MG/ML)	INJECTABLE / INJECTION	AP	2011-09-16	`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	A091375-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091375-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091375-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091375-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091375-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091375-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091375-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091375-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091375-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091375-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091375-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091375-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091375-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091375-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091375-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091375-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091375-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091375-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091375-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091375-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091375-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091375-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091375-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091375-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091375-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091375-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091375-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091375-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091375-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091375-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091375-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091375-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091375-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091375-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091375-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091375-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091375-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091375-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091375-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091375-001	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	500 mg/100mL

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
e680c759-16c5-4532-9c9c-f42c8c3df74a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1	Product name	1	20180821
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
5a6c788d-375b-4565-a8ae-67c179a30c93	Product name	1	20180212
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9721-01	Levofloxacin	100 mL in 1 BAG	INJECTION, SOLUTION	100		12
0143-9721-24	Levofloxacin	24 in 1 CARTON	INJECTION, SOLUTION	24		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9721-01	ML - Milliliter	0143-9721	4f7ffbd1-d911-4ec3-b828-3cd7ff9fc0f7	1	2013-02-13
0143-9721-24	ML - Milliliter	0143-9721	1d2bf451-0858-4573-afa9-f7bf8356056c	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	LEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LEVOFLOXACIN INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9721	LEVOFLOXACIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	12	Current NDC, Legacy NDC, 2 package rows	20190329_e680c759-16c5-4532-9c9c-f42c8c3df74a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levofloxacin	LEVOFLOXACIN	Hikma Pharmaceuticals USA Inc.	e680c759-16c5-4532-9c9c-f42c8c3df74a	2019-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091375 application number: ANDA091375 ndc (product): 0143-9721
Levofloxacin	LEVOFLOXACIN	Hikma Pharmaceuticals USA Inc.	f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5	2019-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091375 application number: ANDA091375

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	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665507	levoFLOXacin 500 MG in 100 ML Injection	PSN	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665515	levoFLOXacin 750 MG in 150 ML Injection	PSN	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665507	100 ML levofloxacin 5 MG/ML Injection	SCD	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665515	150 ML levofloxacin 5 MG/ML Injection	SCD	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665497	50 ML levofloxacin 5 MG/ML Injection	SCD	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665497	levofloxacin 250 MG per 50 ML Injection	SY	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665507	levofloxacin 500 MG per 100 ML Injection	SY	e680c759-16c5-4532-9c9c-f42c8c3df74a	12
1665515	levofloxacin 750 MG per 150 ML Injection	SY	e680c759-16c5-4532-9c9c-f42c8c3df74a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9721-01	00143972101	100 mL in 1 BAG	100 ml					Historical
0143-9721-24	00143972124	24 BAG in 1 CARTON (0143-9721-24) / 100 mL in 1 BAG (0143-9721-01)	24 bag	2011-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2019-03-28	HUMAN PRESCRIPTION DRUG LABEL	12