Lioresal

Product NDC: 58281-560
11-digit product format: 582810560
Labeler code: 58281
Product ID: 58281-560_824b1807-be48-4239-bfdc-2d1d15b42c71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: INJECTION
Route: INTRATHECAL
Labeler: Medtronic Neuromodulation
Application: NDA020075
Marketing category: NDA
Marketing start: 1992-06-17
Marketing end: 0000-00-00
Substance: BACLOFEN
Active strength: 1 mg/mL
Pharmacologic classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	58281-560		I	Inactivated by FDA	2026-10-05
excluded package	package	58281-560	58281-560-01	I	Inactivated by FDA	2026-10-05
excluded package	package	58281-560	58281-560-02	I	Inactivated by FDA	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 2 · 66 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	58281-560-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58281-560-01	`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	58281-560-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58281-560-01	`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	58281-560-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58281-560-01	`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	58281-560-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58281-560-01	`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	58281-560-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58281-560-01	`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	58281-560-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58281-560-01	`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	58281-560-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58281-560-01	`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	58281-560-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58281-560-01	`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	58281-560-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58281-560-01	`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	58281-560-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58281-560-01	`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	58281-560-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58281-560-01	`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	58281-560-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58281-560-01	`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	58281-560-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58281-560-01	`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	58281-560-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58281-560-01	`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	58281-560-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58281-560-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58281-560-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58281-560-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58281-560-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58281-560-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58281-560-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58281-560-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58281-560-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58281-560-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58281-560-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58281-560-01	`e2bbac7714bc…`	`27bdfed8d636…`

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	TE codes	RLD / RS	Approval date
N020075-001	LIORESAL	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17
N020075-002	LIORESAL	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17
N020075-003	LIORESAL	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020075-001	AP
N020075-002	AP
N020075-003	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 · 129 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
2026-09-14 22:38:34	2026-08	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020075-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020075-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020075-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020075-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020075-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020075-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020075-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020075-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020075-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020075-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020075-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020075-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020075-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020075-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020075-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020075-001	AP	1	`301d65b070ca…`

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
1e25d01b-2e92-4765-bec7-8a0fd7bdc346	Product name	2	20251208
1b1393e5-f2d8-42f5-a070-e3416d619667	Product name	1	20250804
88583480-702d-4dfe-a31c-9c00abd818f8	Product name	7	20250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83d	Product name	2	20240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9d	Product name	1	20220613
ef6bc0bf-8134-f06b-70d9-4980df6f808e	Product name	5	20210615
eeec0918-7a2f-44bf-83d6-1216e507adbf	Product name	3	20191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75	Product name	1	20190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58281-560-01	2020-01-31	C162847	48780-1	9d75b9d0-618a-f424-e053-dadaa90a57ce	351cde63-00fa-404a-92df-cb055e991840
58281-560-02	2020-01-31	C162847	48780-1	9d75b9d0-618a-f424-e053-dadaa90a57ce	351cde63-00fa-404a-92df-cb055e991840

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58281-560-01	Lioresal	20 mL in 1 AMPULE	INJECTION	20	12
58281-560-01	Lioresal	1 in 1 PACKAGE, COMBINATION	INJECTION	1	12
58281-560-02	Lioresal	20 mL in 1 AMPULE	INJECTION	20	12
58281-560-02	Lioresal	2 in 1 PACKAGE, COMBINATION	INJECTION	2	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58281-560-01	ML - Milliliter	58281-560	175e9ee2-5f46-4b6e-ad1c-37a5c3b7b9eb	1	2012-07-24
58281-560-02	ML - Milliliter	58281-560	40feb491-9c1c-4b6b-b40a-ae6f27645786	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
baclofen	ACTIVE INGREDIENT	H789N3FKE8	LIORESAL (BACLOFEN) INJECTION [MEDTRONIC NEUROMODULATION]	10
baclofen	ACTIVE MOIETY	H789N3FKE8	LIORESAL (BACLOFEN) INJECTION [MEDTRONIC NEUROMODULATION]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58281-560	LIORESAL (BACLOFEN) INJECTION [MEDTRONIC NEUROMODULATION]	12	Legacy NDC, 4 package rows	20161013_351cde63-00fa-404a-92df-cb055e991840.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
Lioresal (baclofen)	BACLOFEN	Amneal Pharmaceuticals LLC	6f3bdcc0-ffc8-4911-8c35-958c8103a2c5	2022-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020075 application number: NDA020075

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H789N3FKE8	BACLOFEN	1134-47-0	BACLOFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308516	baclofen 0.05 MG in 1 ML (50 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
308517	baclofen 10 MG in 20 ML (500 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
1666622	baclofen 10 MG in 5 ML (2,000 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
1666613	baclofen 40 MG in 20 ML (2,000 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
805679	LIORESAL INTRATHECAL 0.05 MG in 1 ML (50 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
805678	LIORESAL INTRATHECAL 10 MG in 20 ML (500 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
1666623	LIORESAL INTRATHECAL 10 MG in 5 ML (2,000 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
1666620	LIORESAL INTRATHECAL 40 MG in 20 ML (2,000 MCG/ML) Injection	PSN	351cde63-00fa-404a-92df-cb055e991840	12
805679	1 ML baclofen 0.05 MG/ML Injection [Lioresal]	SBD	351cde63-00fa-404a-92df-cb055e991840	12
805678	20 ML baclofen 0.5 MG/ML Injection [Lioresal]	SBD	351cde63-00fa-404a-92df-cb055e991840	12
1666620	20 ML baclofen 2 MG/ML Injection [Lioresal]	SBD	351cde63-00fa-404a-92df-cb055e991840	12
1666623	5 ML baclofen 2 MG/ML Injection [Lioresal]	SBD	351cde63-00fa-404a-92df-cb055e991840	12
308516	1 ML baclofen 0.05 MG/ML Injection	SCD	351cde63-00fa-404a-92df-cb055e991840	12
308517	20 ML baclofen 0.5 MG/ML Injection	SCD	351cde63-00fa-404a-92df-cb055e991840	12
1666613	20 ML baclofen 2 MG/ML Injection	SCD	351cde63-00fa-404a-92df-cb055e991840	12
1666622	5 ML baclofen 2 MG/ML Injection	SCD	351cde63-00fa-404a-92df-cb055e991840	12
805679	1 ML Lioresal 0.05 MG/ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
805678	20 ML Lioresal 0.5 MG/ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
1666620	20 ML Lioresal 2 MG/ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
1666623	5 ML Lioresal 2 MG/ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
308516	baclofen 0.05 MG per 1 ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
1666622	baclofen 10 MG per 5 ML (2,000 MCG/ML) Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
308517	baclofen 10,000 MCG per 20 ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
1666613	baclofen 40,000 MCG per 20 ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
308516	baclofen 50 MCG per 1 ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
805679	Lioresal 0.05 MG per 1 ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
805678	Lioresal 10 MG per 20 ML (500 MCG/ML) Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
1666623	Lioresal 10 MG per 5 ML (2,000 MCG/ML) Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
1666620	Lioresal 40 MG per 20 ML (2,000 MCG/ML) Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12
805679	Lioresal 50 MCG per 1 ML Injection	SY	351cde63-00fa-404a-92df-cb055e991840	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
58281-560-01	58281056001	20 mL in 1 AMPULE	20 ml	Historical
58281-560-02	58281056002	20 mL in 1 AMPULE	20 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lioresal - Medtronic Neuromodulation \| Novartis Pharma AG	Medtronic Neuromodulation \| Novartis Pharma AG	2016-10-07	HUMAN PRESCRIPTION DRUG LABEL	12