Baclofen

Product NDC: 31722-998
11-digit product format: 317220998
Labeler code: 31722
Product ID: 31722-998_896572e4-f389-4b66-9a0b-4b83e71481b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA212378
Marketing category: ANDA
Marketing start: 2020-10-09
Marketing end: 0000-00-00
Substance: BACLOFEN
Active strength: 10 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: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	31722-998		I	Inactivated by FDA	2026-10-12
excluded package	package	31722-998	31722-998-01	I	Inactivated by FDA	2026-10-12
excluded package	package	31722-998	31722-998-05	I	Inactivated by FDA	2026-10-12
excluded package	package	31722-998	31722-998-10	I	Inactivated by FDA	2026-10-12

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	Approval date
A212378-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09
A212378-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09
A212378-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212378-001	AB
A212378-002	AB
A212378-003	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 · 111 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
2026-09-14 22:38:34	2026-08	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A212378-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212378-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212378-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212378-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212378-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212378-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212378-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212378-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212378-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-001	AB	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, Related label table
NDC	Effective	Related label
31722-998-01	2026-01-29	Baclofen Tablets, USP Rx only
31722-998-05	2026-01-29	Baclofen Tablets, USP Rx only
31722-998-10	2026-01-29	Baclofen Tablets, USP Rx only
31722-998-01	2023-10-11	Baclofen Tablets, USP Rx only
31722-998-05	2023-10-11	Baclofen Tablets, USP Rx only
31722-998-10	2023-10-11	Baclofen Tablets, USP Rx only
31722-998-01	2023-01-30	Baclofen Tablets, USP Rx only
31722-998-05	2023-01-30	Baclofen Tablets, USP Rx only
31722-998-10	2023-01-30	Baclofen Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-998-01	Baclofen	100 in 1 BOTTLE	TABLET	100	3
31722-998-05	Baclofen	500 in 1 BOTTLE	TABLET	500	3
31722-998-10	Baclofen	1000 in 1 BOTTLE	TABLET	1000	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-998-01	EA - Each	31722-998	0531779f-a41d-4aea-8fdb-8159c1ae9dcd	1	2021-01-08
31722-998-10	EA - Each	31722-998	ca3f1a0b-c87f-43ec-b427-bbe56e640549	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-998	BACLOFEN TABLET [CAMBER PHARMACEUTICALS, INC.]	3	Legacy NDC, 3 package rows	20231012_ce48b5de-92d3-424e-ba70-c1f2edb28f66.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Bryant Ranch Prepack	f9cf294a-85d1-4321-af68-4279b20c4b71	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	2cd15814-5f70-4c65-9f43-367495486ecd	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	edef7819-875f-4855-8f1f-32407f82e9dc	2022-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378

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
197391	baclofen 10 MG Oral Tablet	PSN	80a4c6f7-4f02-493c-9263-62e1c90404ba	104
197391	baclofen 10 MG Oral Tablet	SCD	80a4c6f7-4f02-493c-9263-62e1c90404ba	104
197391	baclofen 10 MG Oral Tablet	PSN	2cd15814-5f70-4c65-9f43-367495486ecd	103
197391	baclofen 10 MG Oral Tablet	SCD	2cd15814-5f70-4c65-9f43-367495486ecd	103
197391	baclofen 10 MG Oral Tablet	PSN	f9cf294a-85d1-4321-af68-4279b20c4b71	101
197391	baclofen 10 MG Oral Tablet	SCD	f9cf294a-85d1-4321-af68-4279b20c4b71	101
197391	baclofen 10 MG Oral Tablet	PSN	c85a1884-f46f-5cd4-e053-2a95a90a3e27	8
197391	baclofen 10 MG Oral Tablet	SCD	c85a1884-f46f-5cd4-e053-2a95a90a3e27	8
197391	baclofen 10 MG Oral Tablet	PSN	ce48b5de-92d3-424e-ba70-c1f2edb28f66	3
197391	baclofen 10 MG Oral Tablet	PSN	edef7819-875f-4855-8f1f-32407f82e9dc	3
197392	baclofen 20 MG Oral Tablet	PSN	ce48b5de-92d3-424e-ba70-c1f2edb28f66	3
430902	baclofen 5 MG Oral Tablet	PSN	ce48b5de-92d3-424e-ba70-c1f2edb28f66	3
197391	baclofen 10 MG Oral Tablet	SCD	ce48b5de-92d3-424e-ba70-c1f2edb28f66	3
197391	baclofen 10 MG Oral Tablet	SCD	edef7819-875f-4855-8f1f-32407f82e9dc	3
197392	baclofen 20 MG Oral Tablet	SCD	ce48b5de-92d3-424e-ba70-c1f2edb28f66	3
430902	baclofen 5 MG Oral Tablet	SCD	ce48b5de-92d3-424e-ba70-c1f2edb28f66	3
197391	baclofen 10 MG Oral Tablet	PSN	c31518c9-b3b5-acc7-e053-2995a90a27d9	2
197391	baclofen 10 MG Oral Tablet	SCD	c31518c9-b3b5-acc7-e053-2995a90a27d9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-998-01	31722099801	100 TABLET in 1 BOTTLE (31722-998-01)	100 tablet	2020-10-15	0000-00-00	No	No	Current
31722-998-05	31722099805	500 TABLET in 1 BOTTLE (31722-998-05)	500 tablet	2020-10-15	0000-00-00	No	No	Current
31722-998-10	31722099810	1000 TABLET in 1 BOTTLE (31722-998-10)	1000 tablet	2020-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets, USP Rx only	REMEDYREPACK INC.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	6
Baclofen Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	8
Baclofen Tablets, USP Rx only	Bryant Ranch Prepack	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	104
Baclofen Tablets, USP Rx only	Preferred Pharmaceuticals, Inc.	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	3
Baclofen Tablets, USP Rx only	Bryant Ranch Prepack	2023-10-19	HUMAN PRESCRIPTION DRUG LABEL	101
Baclofen Tablets, USP Rx only	Bryant Ranch Prepack	2023-10-18	HUMAN PRESCRIPTION DRUG LABEL	103
Baclofen Tablets, USP Rx only	Camber Pharmaceuticals, Inc. \| Innogenix, LLC.	2023-10-08	HUMAN PRESCRIPTION DRUG LABEL	3
Baclofen Tablets, USP Rx only	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	3
Baclofen Tablets, USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2022-09-08	HUMAN PRESCRIPTION DRUG LABEL	3
Baclofen Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2022-08-16	HUMAN PRESCRIPTION DRUG LABEL	2
Baclofen Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2021-05-26	HUMAN PRESCRIPTION DRUG LABEL	1