Baclofen

Product NDC: 63739-480
11-digit product format: 637390480
Labeler code: 63739
Product ID: 63739-480_b4ca1e70-fd8b-74a9-e053-2a95a90af1b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Mckesson Corporation DBA SKY Packaginng
Application: ANDA078401
Marketing category: ANDA
Marketing start: 2011-01-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-480		D	Discontinued by firm		2026-08-07
excluded package	package	63739-480	63739-480-10	D	Discontinued by firm		2026-08-07

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

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
A078401-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB		2009-09-18
A078401-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		2009-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078401-001	AB
A078401-002	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 · 82 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	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078401-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078401-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078401-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078401-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078401-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078401-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078401-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078401-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078401-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078401-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078401-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078401-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078401-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078401-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078401-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078401-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078401-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078401-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-480-10	2020-07-22	C162847	48780-1	ab0e2407-336d-f274-e053-dbdaa90a6471	Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-480-10	EA - Each	63739-480	a225831a-721b-4ac9-8849-c467f37d4e23	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	4
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-480	BACLOFEN TABLET [MCKESSON CORPORATION DBA SKY PACKAGINNG]	19	Legacy NDC	20250426_d0644a68-d1bf-4fe0-92e6-b79037cf4d12.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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	A-S Medication Solutions	7ee42a29-21c2-47f8-a5b3-f3af115b665d	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401
Baclofen	BACLOFEN	Northstar RxLLC	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c534d-4fa3-0a2f-e053-2995a90ab52f	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	9edc00c6-c281-4e81-b176-44b7536f71f2	2020-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401

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
63739-480-10	63739048010	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-480-10) > 10 TABLET in 1 BLISTER PACK	10 blister pack	2016-05-04	0000-00-00	No	No	Current