Baclofen

Product NDC: 0832-1025
11-digit product format: 008321025
Labeler code: 0832
Product ID: 0832-1025_44afdf24-9775-4730-af93-82564899d921
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA074584
Marketing category: ANDA
Marketing start: 2010-10-20
Marketing end: 0000-00-00
Substance: BACLOFEN
Active strength: 20 mg/1
Pharmacologic classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0832-1025		D	Discontinued by firm	2026-08-17
excluded package	package	0832-1025	0832-1025-00	D	Discontinued by firm	2026-08-17
excluded package	package	0832-1025	0832-1025-09	D	Discontinued by firm	2026-08-17
excluded package	package	0832-1025	0832-1025-10	D	Discontinued by firm	2026-08-17
excluded package	package	0832-1025	0832-1025-50	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 · 60 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	0832-1025-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0832-1025-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0832-1025-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0832-1025-50	`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	0832-1025-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0832-1025-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0832-1025-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0832-1025-50	`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	0832-1025-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0832-1025-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0832-1025-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0832-1025-50	`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	0832-1025-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0832-1025-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0832-1025-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0832-1025-50	`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	0832-1025-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0832-1025-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0832-1025-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0832-1025-50	`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	0832-1025-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0832-1025-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0832-1025-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0832-1025-50	`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	0832-1025-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0832-1025-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0832-1025-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0832-1025-50	`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	0832-1025-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0832-1025-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0832-1025-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0832-1025-50	`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	0832-1025-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0832-1025-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0832-1025-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0832-1025-50	`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	0832-1025-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0832-1025-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0832-1025-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0832-1025-50	`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	0832-1025-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0832-1025-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0832-1025-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0832-1025-50	`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	0832-1025-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0832-1025-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0832-1025-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0832-1025-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A074584-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		1996-08-19
A074584-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB		1996-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074584-001	AB
A074584-002	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A074584-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074584-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074584-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074584-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074584-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074584-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074584-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074584-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074584-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074584-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074584-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074584-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074584-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074584-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074584-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074584-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074584-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074584-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-1025-00	EA - Each	0832-1025	cb90abc8-6374-4e41-92ad-b2782fabd312	1	2012-07-24
0832-1025-09	EA - Each	0832-1025	15df4b34-640f-4e39-aca5-f6019631a3cf	1	2012-07-24
0832-1025-10	EA - Each	0832-1025	d299e269-6923-4e16-b89b-8ee6c69d8d20	1	2012-07-24
0832-1025-50	EA - Each	0832-1025	ba7f2129-3985-4dc3-8db5-a735ea71772e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3980
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3980
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3980
crospovidone	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3980
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3980
povidone	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3980
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, INC.]	7
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, INC.]	7
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, INC.]	7
crospovidone	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, INC.]	7
povidones	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, INC.]	7

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Upsher-Smith Laboratories, LLC	b2747a9d-5fca-4657-9e4b-4112607f30d8	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074584 application number: ANDA074584
Baclofen	BACLOFEN	A-S Medication Solutions	e163e7dc-45a5-43c2-b13d-a4453f2c360c	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074584 application number: ANDA074584
Baclofen	BACLOFEN	A-S Medication Solutions	081d478a-2f3f-456e-bcca-00487589da6f	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074584 application number: ANDA074584

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-1025-09	00832102509	90 TABLET in 1 BOTTLE (0832-1025-09)	90 tablet	2010-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS, USP	Upsher-Smith Laboratories, LLC	2020-10-28	HUMAN PRESCRIPTION DRUG LABEL	10
BACLOFEN TABLETS, USP	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	2012-08-08	HUMAN PRESCRIPTION DRUG LABEL	3980