Levofloxacin

Product NDC: 50383-286
Requested package NDC: 50383-286-11
11-digit product format: 503830286
Labeler code: 50383
Product ID: 50383-286_11805cbd-316b-41f6-bf82-e7af2889e563
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA091678
Marketing category: ANDA
Marketing start: 2011-06-21
Marketing end: 0000-00-00
Substance: LEVOFLOXACIN
Active strength: 25 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	50383-286	50383-286-11	D	Discontinued by firm		2026-08-17

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 · 12 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091678-001	LEVOFLOXACIN	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091678-001	AA

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091678-001	LEVOFLOXACIN	250MG/10ML	SOLUTION / ORAL	AA	RS	2011-06-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A091678-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091678-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091678-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091678-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091678-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091678-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091678-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091678-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091678-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091678-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091678-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091678-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091678-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091678-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091678-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091678-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091678-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091678-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091678-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091678-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091678-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091678-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091678-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091678-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091678-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091678-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091678-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091678-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091678-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091678-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091678-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091678-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091678-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091678-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091678-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091678-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091678-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091678-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091678-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091678-001	AA	1	`e64feba35796…`

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50383-286-04	These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-08	These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-11	These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-16	These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996
50383-286-21	These highlights do not include all the information needed to use LEVOFLOXACIN safely and effectively. See full prescribing information for LEVOFLOXACIN. LEVOFLOXACIN oral solution Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-286-04	Levofloxacin	1 in 1 CARTON	SOLUTION	1	27
50383-286-04	Levofloxacin	100 mL in 1 BOTTLE	SOLUTION	100	27
50383-286-08	Levofloxacin	200 mL in 1 BOTTLE	SOLUTION	200	27
50383-286-08	Levofloxacin	1 in 1 CARTON	SOLUTION	1	27
50383-286-10	Levofloxacin	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	27
50383-286-11	Levofloxacin	4 in 1 CASE	SOLUTION	4	27
50383-286-11	Levofloxacin	10 in 1 TRAY	SOLUTION	10	27
50383-286-16	Levofloxacin	480 mL in 1 BOTTLE	SOLUTION	480	27
50383-286-16	Levofloxacin	1 in 1 CARTON	SOLUTION	1	27
50383-286-20	Levofloxacin	20 mL in 1 CUP, UNIT-DOSE	SOLUTION	20	27
50383-286-21	Levofloxacin	10 in 1 TRAY	SOLUTION	10	27
50383-286-21	Levofloxacin	4 in 1 CASE	SOLUTION	4	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-286-04	ML - Milliliter	50383-286	63fccffd-ce22-4944-8ebe-0bb4d09c8348	1	2012-07-24
50383-286-08	ML - Milliliter	50383-286	d78afd86-ca6e-49d3-af41-249b22276979	1	2012-07-24
50383-286-10	ML - Milliliter	50383-286	1899d499-bb8d-4076-9d90-bbbb443a0074	1	2014-02-04
50383-286-11	ML - Milliliter	50383-286	8f6badf6-2c01-4a69-ba09-c02f60ea5cf7	1	2014-02-04
50383-286-16	ML - Milliliter	50383-286	e9f4bf6b-7253-4fd0-97b5-acc7159f25ca	1	2012-07-24
50383-286-20	ML - Milliliter	50383-286	3c30225d-af52-4e5f-8178-287397dee65c	1	2014-02-04
50383-286-21	ML - Milliliter	50383-286	2767b0db-d598-479b-ba98-d754ad52721a	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOFLOXACIN	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
LEVOFLOXACIN ANHYDROUS	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
GRAPE	INACTIVE INGREDIENT	6X543N684K	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVOFLOXACIN SOLUTION [HI-TECH PHARMACAL CO., INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-286	LEVOFLOXACIN SOLUTION [AKORN]	27	Legacy NDC, 12 package rows	20221103_c6c7322b-6a89-4d23-90d1-bf9327bd6d91.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	ANI Pharmaceuticals, Inc.	a894e40b-77e4-439b-b0f8-9a5cc7a1dd90	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091678 application number: ANDA091678

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
477391	levoFLOXacin 25 MG in 1 mL Oral Solution	PSN	c6c7322b-6a89-4d23-90d1-bf9327bd6d91	27
477391	levofloxacin 25 MG/ML Oral Solution	SCD	c6c7322b-6a89-4d23-90d1-bf9327bd6d91	27
477391	levofloxacin 25 MG per 1 ML Oral Solution	SY	c6c7322b-6a89-4d23-90d1-bf9327bd6d91	27
477391	levofloxacin 250 MG per 10 ML Oral Solution	SY	c6c7322b-6a89-4d23-90d1-bf9327bd6d91	27
477391	levofloxacin 500 MG per 20 ML Oral Solution	SY	c6c7322b-6a89-4d23-90d1-bf9327bd6d91	27
477391	levoFLOXacin 25 MG in 1 mL Oral Solution	PSN	2b5f951e-4b6f-2c1f-e054-00144ff8d46c	2
477391	levofloxacin 25 MG/ML Oral Solution	SCD	2b5f951e-4b6f-2c1f-e054-00144ff8d46c	2
477391	levofloxacin 25 MG per 1 ML Oral Solution	SY	2b5f951e-4b6f-2c1f-e054-00144ff8d46c	2
477391	levofloxacin 250 MG per 10 ML Oral Solution	SY	2b5f951e-4b6f-2c1f-e054-00144ff8d46c	2
477391	levofloxacin 500 MG per 20 ML Oral Solution	SY	2b5f951e-4b6f-2c1f-e054-00144ff8d46c	2
477391	levoFLOXacin 25 MG in 1 mL Oral Solution	PSN	7e8ff2be-620e-43bf-86d7-78f9d7a5f0ab	1
477391	levofloxacin 25 MG/ML Oral Solution	SCD	7e8ff2be-620e-43bf-86d7-78f9d7a5f0ab	1
477391	levofloxacin 25 MG per 1 ML Oral Solution	SY	7e8ff2be-620e-43bf-86d7-78f9d7a5f0ab	1
477391	levofloxacin 250 MG per 10 ML Oral Solution	SY	7e8ff2be-620e-43bf-86d7-78f9d7a5f0ab	1
477391	levofloxacin 500 MG per 20 ML Oral Solution	SY	7e8ff2be-620e-43bf-86d7-78f9d7a5f0ab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-286-11	50383028611	4 TRAY in 1 CASE (50383-286-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-286-10)	4 tray	2015-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levofloxacin	Akorn \| Akorn Operating Company LLC	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	27
Levofloxacin	ATLANTIC BIOLOGICALS CORP.	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	1
Levofloxacin	Department of State Health Services, Pharmacy Branch	2016-03-11	HUMAN PRESCRIPTION DRUG LABEL	2