Baclofen

Product NDC: 68788-7562
Requested package NDC: 68788-7562-3
11-digit product format: 687887562
Labeler code: 68788
Product ID: 68788-7562_9cc0423d-882e-4eaa-a636-4d81d4250eca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA211659
Marketing category: ANDA
Marketing start: 2018-12-06
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7562	68788-7562-3	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211659-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23
A211659-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23
A211659-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17
A211659-004	BACLOFEN	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211659-001	AB
A211659-002	AB
A211659-003	AB
A211659-004	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 4 · 135 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
2026-02-19 14:30 UTC	2026-02	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 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	A211659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7562-1	EA - Each	68788-7562	56df1b71-1bbb-42c5-a09f-5348820f5dd2	1	2021-10-08
68788-7562-3	EA - Each	68788-7562	5dbcf98d-cda7-4318-8cb4-1a21a81d8d41	1	2021-10-08
68788-7562-6	EA - Each	68788-7562	3882460d-2814-438e-8162-798d4dd85c7f	1	2021-10-08
68788-7562-8	EA - Each	68788-7562	77d25ead-1466-4874-8de6-0da9cf481b7d	1	2021-10-08
68788-7562-9	EA - Each	68788-7562	a66153c0-7556-4766-a58b-7c71e18e53c6	1	2021-10-08

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Cardinal Health 107, LLC	3c87e116-871d-46b8-897b-fc27a17b988d	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	AvPAK	c21095a9-17b1-555a-e053-2a95a90a51fd	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	AvPAK	bc9040d9-1c54-9d62-e053-2a95a90a6ae3	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Coupler LLC	5023c690-fd86-bb7d-e063-6394a90af6cd	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	A-S Medication Solutions	4f84b27a-725a-48e6-a58a-85bbb395f4ae	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	A-S Medication Solutions	5f6a86f9-9658-4210-a47c-62907edfd416	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	A-S Medication Solutions	975fda6d-d929-482b-8be7-60849026dbdd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	American Health Packaging	8b046ee6-28fc-4ab1-b543-414ad0103e5c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Bryant Ranch Prepack	5b92b0a6-ebba-4815-8b94-f2014674399b	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Zydus Lifesciences Limited	bb5c6faa-2933-44d1-8706-8302150be734	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Zydus Pharmaceuticals (USA) Inc.	cfc49176-8d01-4c39-9319-604dd087065c	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659

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
68788-7562-3	68788756203	30 TABLET in 1 BOTTLE (68788-7562-3)	30 tablet	2019-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS USP Rx only	Preferred Pharmaceuticals, Inc.	2021-03-18	HUMAN PRESCRIPTION DRUG LABEL	2