Levofloxacin

Product NDC: 17478-107
11-digit product format: 174780107
Labeler code: 17478
Product ID: 17478-107_1df0a7b7-b4af-4efa-b0b9-74d891c14f4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levofloxacin
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Akorn
Application: ANDA091644
Marketing category: ANDA
Marketing start: 2011-07-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17478-107		I	Inactivated by FDA	2026-08-17
excluded package	package	17478-107	17478-107-20	I	Inactivated by FDA	2026-08-17
excluded package	package	17478-107	17478-107-30	I	Inactivated by FDA	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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-107-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-107-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-107-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-107-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-107-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-107-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-107-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-107-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-107-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-107-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-107-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-107-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-107-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-107-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-107-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-107-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-107-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-107-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-107-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-107-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-107-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-107-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-107-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-107-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-107-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-107-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-107-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-107-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-107-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-107-30	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A091644-001	LEVOFLOXACIN	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20
A091644-002	LEVOFLOXACIN	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091644-001	AP
A091644-002	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 3 · 84 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	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP	RS	2011-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091644-001	LEVOFLOXACIN	EQ 500MG/20ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091644-002	LEVOFLOXACIN	EQ 750MG/30ML (EQ 25MG/ML)	INJECTABLE / INJECTION	AP		2011-06-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A091644-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091644-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091644-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091644-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091644-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091644-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091644-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091644-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091644-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091644-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091644-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091644-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091644-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091644-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091644-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091644-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091644-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091644-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091644-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091644-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091644-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091644-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091644-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091644-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091644-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091644-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091644-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091644-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091644-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091644-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091644-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091644-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091644-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091644-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091644-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091644-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091644-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091644-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091644-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091644-002	AP	1	`bb7c543d1eb4…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-107-20	2024-01-30	C162847	48780-1	1030e365-1718-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use LEVOFLOXACIN INJECTION safely and effectively. See full prescribing information for LEVOFLOXACIN INJECTION. LEVOFLOXACIN Injection, Solution for Intravenous Use Initial U.S. Approval: 1996
17478-107-30	2024-01-30	C162847	48780-1	1030e365-1718-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use LEVOFLOXACIN INJECTION safely and effectively. See full prescribing information for LEVOFLOXACIN INJECTION. LEVOFLOXACIN Injection, Solution for Intravenous Use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-107-20	Levofloxacin	20 mL in 1 VIAL	INJECTION	20	13
17478-107-20	Levofloxacin	1 in 1 CARTON	INJECTION	1	13
17478-107-30	Levofloxacin	1 in 1 CARTON	INJECTION	1	13
17478-107-30	Levofloxacin	30 mL in 1 VIAL	INJECTION	30	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-107-20	ML - Milliliter	17478-107	ba3d6855-f7d6-4db4-97b1-1e6f4515ff98	1	2012-07-24
17478-107-30	ML - Milliliter	17478-107	53d80233-0ff1-4648-ac4f-ff5091b67f55	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Levofloxacin	ACTIVE INGREDIENT	6GNT3Y5LMF	LEVOFLOXACIN INJECTION [AKORN, INC.]	5
Levofloxacin Anhydrous	ACTIVE MOIETY	RIX4E89Y14	LEVOFLOXACIN INJECTION [AKORN, INC.]	5
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	LEVOFLOXACIN INJECTION [AKORN, INC.]	5
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	LEVOFLOXACIN INJECTION [AKORN, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-107	LEVOFLOXACIN INJECTION [AKORN]	13	Legacy NDC, 4 package rows	20220914_4438fed2-7ef5-488f-baa8-39bc65768d1d.zip

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	4438fed2-7ef5-488f-baa8-39bc65768d1d	13
1665519	levoFLOXacin 750 MG in 30 ML Injection	PSN	4438fed2-7ef5-488f-baa8-39bc65768d1d	13
1665517	20 ML levofloxacin 25 MG/ML Injection	SCD	4438fed2-7ef5-488f-baa8-39bc65768d1d	13
1665519	30 ML levofloxacin 25 MG/ML Injection	SCD	4438fed2-7ef5-488f-baa8-39bc65768d1d	13
1665517	levofloxacin 500 MG per 20 ML Injection	SY	4438fed2-7ef5-488f-baa8-39bc65768d1d	13
1665519	levofloxacin 750 MG per 30 ML Injection	SY	4438fed2-7ef5-488f-baa8-39bc65768d1d	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-107-20	17478010720	1 VIAL in 1 CARTON (17478-107-20) > 20 mL in 1 VIAL	1 vial	2011-07-01	0000-00-00	No	No	Current
17478-107-30	17478010730	1 VIAL in 1 CARTON (17478-107-30) > 30 mL in 1 VIAL	1 vial	2011-07-01	0000-00-00	No	No	Current