Baclofen

Product NDC: 0527-1330
11-digit product format: 005271330
Labeler code: 0527
Product ID: 0527-1330_153f6bd7-9462-4d92-b738-48e7807c5919
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA078220
Marketing category: ANDA
Marketing start: 2007-07-01
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: 2026-12-31
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: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197391	Internal RxNorm lookup
197392	Internal RxNorm lookup
430902	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
f84f3f4c-17e6-43f1-9600-63b0b175837b	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
0527-1330-01	Baclofen	100 in 1 BOTTLE, PLASTIC	TABLET	100	19
0527-1330-05	Baclofen	500 in 1 BOTTLE, PLASTIC	TABLET	500	19
0527-1330-10	Baclofen	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1330-01	EA - Each	0527-1330	0cecbbe8-21e4-4120-b138-170ba133ee82	1	2012-07-24
0527-1330-05	EA - Each	0527-1330	d7c14871-9830-45db-bd26-71f26c751419	1	2012-07-24
0527-1330-10	EA - Each	0527-1330	7903a185-bd43-484f-9123-4c010374880d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [LANNETT COMPANY, INC.]	9
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [LANNETT COMPANY, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [LANNETT COMPANY, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [LANNETT COMPANY, INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [LANNETT COMPANY, INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [LANNETT COMPANY, INC.]	9
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PROFICIENT RX LP]	2
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.]	2
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PROFICIENT RX LP]	2
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PROFICIENT RX LP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PROFICIENT RX LP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [PROFICIENT RX LP]	2
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [MAJOR PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1330	BACLOFEN TABLET [LANNETT COMPANY, INC.]	19	Current NDC, Legacy NDC, 3 package rows	20210924_f84f3f4c-17e6-43f1-9600-63b0b175837b.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
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 ndc (product): 0527-1330
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	402a0a2b-95a6-4d22-bedf-826e1f1cd2c3	104
197391	baclofen 10 MG Oral Tablet	PSN	fded79a4-c354-448d-96dd-6dc69c46a013	104
197391	baclofen 10 MG Oral Tablet	SCD	fded79a4-c354-448d-96dd-6dc69c46a013	104
197391	baclofen 10 MG Oral Tablet	SCD	402a0a2b-95a6-4d22-bedf-826e1f1cd2c3	104
197391	baclofen 10 MG Oral Tablet	PSN	12d57610-8c70-4729-b358-56525613a29d	103
197391	baclofen 10 MG Oral Tablet	PSN	54bea140-c537-44a2-8d1d-bfb20471f4d8	103
197391	baclofen 10 MG Oral Tablet	SCD	54bea140-c537-44a2-8d1d-bfb20471f4d8	103
197391	baclofen 10 MG Oral Tablet	SCD	12d57610-8c70-4729-b358-56525613a29d	103
197391	baclofen 10 MG Oral Tablet	PSN	fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f	101
197391	baclofen 10 MG Oral Tablet	SCD	fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f	101
197391	baclofen 10 MG Oral Tablet	PSN	cfcf519f-5d15-431d-89c8-961a0c38ba60	26
197392	baclofen 20 MG Oral Tablet	PSN	cfcf519f-5d15-431d-89c8-961a0c38ba60	26
197391	baclofen 10 MG Oral Tablet	SCD	cfcf519f-5d15-431d-89c8-961a0c38ba60	26
197392	baclofen 20 MG Oral Tablet	SCD	cfcf519f-5d15-431d-89c8-961a0c38ba60	26
197391	baclofen 10 MG Oral Tablet	PSN	f84f3f4c-17e6-43f1-9600-63b0b175837b	19
197392	baclofen 20 MG Oral Tablet	PSN	f84f3f4c-17e6-43f1-9600-63b0b175837b	19
430902	baclofen 5 MG Oral Tablet	PSN	f84f3f4c-17e6-43f1-9600-63b0b175837b	19
197391	baclofen 10 MG Oral Tablet	SCD	f84f3f4c-17e6-43f1-9600-63b0b175837b	19
197392	baclofen 20 MG Oral Tablet	SCD	f84f3f4c-17e6-43f1-9600-63b0b175837b	19
430902	baclofen 5 MG Oral Tablet	SCD	f84f3f4c-17e6-43f1-9600-63b0b175837b	19
197391	baclofen 10 MG Oral Tablet	PSN	ae732bdc-5178-4565-8219-d1787a5211a6	11
197392	baclofen 20 MG Oral Tablet	PSN	ae732bdc-5178-4565-8219-d1787a5211a6	11
197391	baclofen 10 MG Oral Tablet	SCD	ae732bdc-5178-4565-8219-d1787a5211a6	11
197392	baclofen 20 MG Oral Tablet	SCD	ae732bdc-5178-4565-8219-d1787a5211a6	11
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
197391	baclofen 10 MG Oral Tablet	PSN	924a01fb-0ed0-4f73-9304-d6c5b9961d66	8
197392	baclofen 20 MG Oral Tablet	PSN	924a01fb-0ed0-4f73-9304-d6c5b9961d66	8
197391	baclofen 10 MG Oral Tablet	SCD	924a01fb-0ed0-4f73-9304-d6c5b9961d66	8
197392	baclofen 20 MG Oral Tablet	SCD	924a01fb-0ed0-4f73-9304-d6c5b9961d66	8
197391	baclofen 10 MG Oral Tablet	PSN	b6309f7f-e8ed-4233-b160-3838ff2bab13	6
197391	baclofen 10 MG Oral Tablet	PSN	8ed7ca43-28e3-ef10-e053-2995a90af4a9	6
197391	baclofen 10 MG Oral Tablet	SCD	b6309f7f-e8ed-4233-b160-3838ff2bab13	6
197391	baclofen 10 MG Oral Tablet	SCD	8ed7ca43-28e3-ef10-e053-2995a90af4a9	6
197391	baclofen 10 MG Oral Tablet	PSN	71cad25b-9c6c-6797-e053-2a95a90a7b19	1
197391	baclofen 10 MG Oral Tablet	SCD	71cad25b-9c6c-6797-e053-2a95a90a7b19	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1330-01	00527133001	100 TABLET in 1 BOTTLE, PLASTIC (0527-1330-01)	100 tablet	2007-07-01	0000-00-00	No	No	Current
0527-1330-05	00527133005	500 TABLET in 1 BOTTLE, PLASTIC (0527-1330-05)	500 tablet	2007-07-01	0000-00-00	No	No	Current
0527-1330-10	00527133010	1000 TABLET in 1 BOTTLE, PLASTIC (0527-1330-10)	1000 tablet	2007-07-01	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
Baclofen Tablets, USP	Major Pharmaceuticals	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	11
Baclofen Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	26
Baclofen Tablets, USP	Bryant Ranch Prepack	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	101
Baclofen Tablets, USP	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	104
Baclofen Tablets, USP	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	103
Baclofen Tablets, USP	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	103
Baclofen Tablets, USP	REMEDYREPACK INC.	2024-01-05	HUMAN PRESCRIPTION DRUG LABEL	9
Baclofen Tablets, USP	Bryant Ranch Prepack	2023-10-19	HUMAN PRESCRIPTION DRUG LABEL	104
BACLOFEN	Direct_Rx	2023-09-28	HUMAN PRESCRIPTION DRUG LABEL	6
Baclofen Tablets, USP	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	14
Baclofen Tablets, USP 8285501/0520 Rx only	American Health Packaging	2022-11-04	HUMAN PRESCRIPTION DRUG LABEL	8
BACLOFEN	DIRECT RX	2022-09-27	HUMAN PRESCRIPTION DRUG LABEL	6
Baclofen Tablets, USP	NuCare Pharmaceuticals,Inc.	2022-02-07	HUMAN PRESCRIPTION DRUG LABEL	2
BACLOFEN TABLETS, USP	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	9
Baclofen Tablets, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2022-01-04	HUMAN PRESCRIPTION DRUG LABEL	3
BACLOFEN TABLETS, USP	Lake Erie Medical DBA Quality Care Products LLC	2021-09-22	HUMAN PRESCRIPTION DRUG LABEL	5
Baclofen Tablets, USP	Lannett Company, Inc.	2021-02-24	HUMAN PRESCRIPTION DRUG LABEL	19
BACLOFEN TABLETS, USP	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	4
BACLOFEN TABLETS, USP	Proficient Rx LP	2020-05-01	HUMAN PRESCRIPTION DRUG LABEL	8
BACLOFEN TABLETS, USP	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
BACLOFEN TABLETS, USP	McKesson Corporation dba SKY Packaging \| McKesson Corporation dba RX Pak	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	9
BACLOFEN TABLETS, USP	Medsource Pharmaceuticals	2018-07-24	HUMAN PRESCRIPTION DRUG LABEL	1