Baclofen

Product NDC: 0115-1012
11-digit product format: 001151012
Labeler code: 0115
Product ID: 0115-1012_c9f07c77-925d-41ba-b5e8-d6e8665ef27c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA077971
Marketing category: ANDA
Marketing start: 2007-10-27
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: 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0115-1012		D	Discontinued by firm	2026-10-05
excluded package	package	0115-1012	0115-1012-01	D	Discontinued by firm	2026-10-05
excluded package	package	0115-1012	0115-1012-02	D	Discontinued by firm	2026-10-05
excluded package	package	0115-1012	0115-1012-03	D	Discontinued by firm	2026-10-05
excluded package	package	0115-1012	0115-1012-08	D	Discontinued by firm	2026-10-05

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	Approval date
A077971-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	2007-10-26
A077971-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	2007-10-26
A077971-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	2021-07-07

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 · 121 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077971-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077971-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077971-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077971-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077971-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077971-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077971-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077971-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077971-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077971-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077971-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077971-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077971-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077971-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077971-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077971-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077971-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077971-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077971-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077971-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077971-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077971-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077971-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077971-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077971-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077971-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077971-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077971-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077971-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077971-003	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1012-01	EA - Each	0115-1012	5aff754d-791f-46d0-850b-27bd1c08b132	1	2021-01-08
0115-1012-03	EA - Each	0115-1012	9f2dfaad-d210-4806-adff-bde5fe04cb71	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1012	BACLOFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	8	Legacy NDC	20231231_198a9d33-25de-4509-9f7d-166ce0c53a0c.zip

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
0115-1012-01	00115101201	100 TABLET in 1 BOTTLE (0115-1012-01)	100 tablet	2007-10-27	0000-00-00	No	No	Current
0115-1012-02	00115101202	500 TABLET in 1 BOTTLE (0115-1012-02)	500 tablet	2007-10-27	0000-00-00	No	No	Current
0115-1012-03	00115101203	1000 TABLET in 1 BOTTLE (0115-1012-03)	1000 tablet	2007-10-27	0000-00-00	No	No	Current
0115-1012-08	00115101208	30 TABLET in 1 BOTTLE (0115-1012-08)	30 tablet	2007-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS, USP 5 mg, 10 mg and 20 mg Rx only	Amneal Pharmaceuticals of New York LLC	2023-12-30	HUMAN PRESCRIPTION DRUG LABEL	8
BACLOFEN TABLETS, USP 10 mg and 20 mg Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2023-02-24	HUMAN PRESCRIPTION DRUG LABEL	3