Baclofen

Product NDC: 0615-3542
11-digit product format: 006153542
Labeler code: 0615
Product ID: 0615-3542_2ed52df2-0435-4344-8754-0d4c53e88f7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA072235
Marketing category: ANDA
Marketing start: 2010-07-15
Marketing end: 2023-07-31
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: 0000-00-00
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	0615-3542		D	Discontinued by firm	2026-08-10
excluded package	package	0615-3542	0615-3542-31	D	Discontinued by firm	2026-08-10
excluded package	package	0615-3542	0615-3542-39	D	Discontinued by firm	2026-08-10

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 · 36 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	0615-3542-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-3542-39	`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	0615-3542-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-3542-39	`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	0615-3542-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-3542-39	`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	0615-3542-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-3542-39	`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	0615-3542-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-3542-39	`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	0615-3542-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-3542-39	`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	0615-3542-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-3542-39	`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	0615-3542-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-3542-39	`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	0615-3542-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-3542-39	`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	0615-3542-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-3542-39	`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	0615-3542-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-3542-39	`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	0615-3542-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-3542-39	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A072235-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072235-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072235-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072235-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072235-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072235-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072235-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072235-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072235-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072235-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072235-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072235-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072235-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072235-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072235-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072235-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072235-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072235-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072235-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072235-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072235-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072235-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072235-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072235-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072235-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072235-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072235-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072235-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072235-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072235-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072235-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072235-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072235-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072235-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072235-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072235-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072235-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072235-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072235-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072235-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072235-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072235-001	AB	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6

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
Baclofen	BACLOFEN	Proficient Rx LP	9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072235 application number: ANDA072235
Baclofen	BACLOFEN	Teva Pharmaceuticals USA, Inc.	5648c772-50cb-4961-996e-e68a8eb699ea	2019-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072235 application number: ANDA072235

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
0615-3542-39	00615354239	30 TABLET in 1 BLISTER PACK (0615-3542-39)	30 tablet	2010-07-15	2023-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS USP	NCS HealthCare of KY, LLC dba Vangard Labs	2015-09-04	HUMAN PRESCRIPTION DRUG LABEL	8