Baclofen

Product NDC: 68788-9246
11-digit product format: 687889246
Labeler code: 68788
Product ID: 68788-9246_b605ca0d-58f9-4995-b87e-e5b186fa9ce7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA078220
Marketing category: ANDA
Marketing start: 2014-10-22
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: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
H789N3FKE8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197391	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58416ceb-994f-4571-afbd-c2171823f528	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-9246-1	Baclofen	100 in 1 BOTTLE, PLASTIC	TABLET	100	10
68788-9246-3	Baclofen	30 in 1 BOTTLE, PLASTIC	TABLET	30	10
68788-9246-6	Baclofen	60 in 1 BOTTLE, PLASTIC	TABLET	60	10
68788-9246-8	Baclofen	120 in 1 BOTTLE, PLASTIC	TABLET	120	10
68788-9246-9	Baclofen	90 in 1 BOTTLE, PLASTIC	TABLET	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-9246-1	EA - Each	68788-9246	150c5272-1bc0-4f45-bfe3-d2e3ea22192f	1	2021-12-08
68788-9246-3	EA - Each	68788-9246	78f5697b-82bf-43be-950f-c312ea38dcf3	1	2021-12-08
68788-9246-6	EA - Each	68788-9246	8eaf70b9-ee0e-484e-8f85-82b2cbce252f	1	2021-12-08
68788-9246-8	EA - Each	68788-9246	22f97b72-b286-4ea2-bf23-7a9b1ca516a7	1	2021-12-08
68788-9246-9	EA - Each	68788-9246	f0a08cd4-b1c1-4829-b9c7-3deccccb78de	1	2021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9246	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 5 package rows	20240306_58416ceb-994f-4571-afbd-c2171823f528.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 · 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	2278954a-7605-426a-ae85-1bf0a3117420	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Preferred Pharmaceuticals, Inc.	58416ceb-994f-4571-afbd-c2171823f528	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220 ndc (product): 68788-9246
Baclofen	BACLOFEN	Major Pharmaceuticals	ae732bdc-5178-4565-8219-d1787a5211a6	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	cfcf519f-5d15-431d-89c8-961a0c38ba60	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	402a0a2b-95a6-4d22-bedf-826e1f1cd2c3	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	54bea140-c537-44a2-8d1d-bfb20471f4d8	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	12d57610-8c70-4729-b358-56525613a29d	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	fded79a4-c354-448d-96dd-6dc69c46a013	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Lannett Company, Inc.	f84f3f4c-17e6-43f1-9600-63b0b175837b	2021-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	d9e5a8b9-1524-41b4-942f-f95015dd17f9	2020-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220

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	58416ceb-994f-4571-afbd-c2171823f528	10
197391	baclofen 10 MG Oral Tablet	SCD	58416ceb-994f-4571-afbd-c2171823f528	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9246-1	68788924601	100 TABLET in 1 BOTTLE, PLASTIC (68788-9246-1)	100 tablet	2014-10-22	0000-00-00	No	No	Current
68788-9246-3	68788924603	30 TABLET in 1 BOTTLE, PLASTIC (68788-9246-3)	30 tablet	2014-10-22	0000-00-00	No	No	Current
68788-9246-6	68788924606	60 TABLET in 1 BOTTLE, PLASTIC (68788-9246-6)	60 tablet	2014-10-22	0000-00-00	No	No	Current
68788-9246-8	68788924608	120 TABLET in 1 BOTTLE, PLASTIC (68788-9246-8)	120 tablet	2014-10-22	0000-00-00	No	No	Current
68788-9246-9	68788924609	90 TABLET in 1 BOTTLE, PLASTIC (68788-9246-9)	90 tablet	2014-10-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets, USP	Preferred Pharmaceuticals, Inc.	2026-01-26	HUMAN PRESCRIPTION DRUG LABEL	10