Baclofen

Product NDC: 63629-1286
Requested package NDC: 63629-1286-1
11-digit product format: 636291286
Labeler code: 63629
Product ID: 63629-1286_bf500d4b-4dd6-4710-85fa-b62096912c24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077156
Marketing category: ANDA
Marketing start: 2005-08-30
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: 2020-12-31
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	63629-1286	63629-1286-1	D	Discontinued by firm		2026-10-15

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.

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
63629-1286-1	EA - Each	63629-1286	be1c10eb-2704-429e-aac5-c870f9376681	1	2012-07-24
63629-1286-2	EA - Each	63629-1286	fa26a51d-cd18-4c3d-a663-6a7119b0beb5	1	2012-07-24
63629-1286-3	EA - Each	63629-1286	2d74a17d-8235-4fb0-b952-4344f3d2b20c	1	2017-07-07
63629-1286-4	EA - Each	63629-1286	ce7150e3-c896-4a12-8323-725bd298c16a	1	2012-07-24
63629-1286-5	EA - Each	63629-1286	66a740f2-7a2f-4bde-9670-eabe070583f4	1	2015-02-02
63629-1286-6	EA - Each	63629-1286	8f5e170b-8612-4205-bd54-f7258ccc40c9	1	2012-07-24
63629-1286-7	EA - Each	63629-1286	384a27de-a549-4ebf-8ec4-b6f2e1d57b12	1	2015-02-02
63629-1286-8	EA - Each	63629-1286	0d43a855-5e58-4dde-8bec-072d003e9c74	1	2015-02-02
63629-1286-9	EA - Each	63629-1286	1f3f08c8-7c25-41fc-a471-a5338b498bf4	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4

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	Bryant Ranch Prepack	7ed13ef7-329e-40cb-b9b1-31a4bf32ac98	2023-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077156 application number: ANDA077156
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	dd4b9972-0295-4555-a90b-bb087170cfbb	2017-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077156 application number: ANDA077156

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
63629-1286-1	63629128601	30 TABLET in 1 BOTTLE, PLASTIC (63629-1286-1)	30 tablet	2007-07-01	0000-00-00	No	No	Current