Baclofen

Product NDC: 0172-4096
11-digit product format: 001724096
Labeler code: 0172
Product ID: 0172-4096_ba227be6-e946-423c-a9a6-e0626d889ea7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA072234
Marketing category: ANDA
Marketing start: 1988-07-21
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

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 Identifiers#

Field, Values table
Field	Values
Unii	H789N3FKE8
Rxcui	197391, 197392

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	Strength	SPL version
0172-4096-60	Baclofen	100 in 1 BOTTLE	TABLET	100		19
0172-4096-80	Baclofen	1000 in 1 BOTTLE	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
0172-4096-60	EA - Each	0172-4096	fc4535a2-1562-4831-85d4-1cd115b2f587	1	2012-07-24
0172-4096-80	EA - Each	0172-4096	ee681073-3bde-4c88-ab28-e469030c56c1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [IVAX PHARMACEUTICALS, INC.]	12
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	8
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	4
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [PROFICIENT RX LP]	3
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [PROFICIENT RX LP]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [PROFICIENT RX LP]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [PROFICIENT RX LP]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [UNIT DOSE SERVICES]	3
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [DIRECT RX]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0172-4096	BACLOFEN TABLET [TEVA PHARMACEUTICALS USA, INC.]	19	Current NDC, Legacy NDC, 2 package rows	20210518_5648c772-50cb-4961-996e-e68a8eb699ea.zip

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	95755a7b-4a9f-45ea-a381-d3f661150efe	27
197391	baclofen 10 MG Oral Tablet	SCD	95755a7b-4a9f-45ea-a381-d3f661150efe	27
197391	baclofen 10 MG Oral Tablet	PSN	5648c772-50cb-4961-996e-e68a8eb699ea	19
197392	baclofen 20 MG Oral Tablet	PSN	5648c772-50cb-4961-996e-e68a8eb699ea	19
197391	baclofen 10 MG Oral Tablet	SCD	5648c772-50cb-4961-996e-e68a8eb699ea	19
197392	baclofen 20 MG Oral Tablet	SCD	5648c772-50cb-4961-996e-e68a8eb699ea	19
197391	baclofen 10 MG Oral Tablet	PSN	36f8b9c9-4e9d-41e4-b889-05cb948c6718	10
197391	baclofen 10 MG Oral Tablet	SCD	36f8b9c9-4e9d-41e4-b889-05cb948c6718	10
197391	baclofen 10 MG Oral Tablet	PSN	b33c4164-e607-2e27-e053-2a95a90ad7db	7
197391	baclofen 10 MG Oral Tablet	PSN	b981eb16-a195-41da-a186-3e91b63b2def	7
197391	baclofen 10 MG Oral Tablet	SCD	b981eb16-a195-41da-a186-3e91b63b2def	7
197391	baclofen 10 MG Oral Tablet	SCD	b33c4164-e607-2e27-e053-2a95a90ad7db	7
197391	baclofen 10 MG Oral Tablet	PSN	ec9c8b7f-9fb0-4274-9532-2fee335c055d	6
197391	baclofen 10 MG Oral Tablet	SCD	ec9c8b7f-9fb0-4274-9532-2fee335c055d	6
197391	baclofen 10 MG Oral Tablet	PSN	19ec8066-f0e7-4f80-b596-abe7b1ad92cb	5
197391	baclofen 10 MG Oral Tablet	SCD	19ec8066-f0e7-4f80-b596-abe7b1ad92cb	5
197391	baclofen 10 MG Oral Tablet	PSN	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	PSN	06bcfb08-2ada-f803-e063-6394a90a826b	4
197392	baclofen 20 MG Oral Tablet	PSN	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	SCD	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	SCD	06bcfb08-2ada-f803-e063-6394a90a826b	4
197392	baclofen 20 MG Oral Tablet	SCD	d2806494-2042-497c-b5ca-7344f6b01a9c	4
197391	baclofen 10 MG Oral Tablet	PSN	962601f8-7567-4afe-90a0-6df356f5a297	2
197392	baclofen 20 MG Oral Tablet	PSN	962601f8-7567-4afe-90a0-6df356f5a297	2
197391	baclofen 10 MG Oral Tablet	SCD	962601f8-7567-4afe-90a0-6df356f5a297	2
197392	baclofen 20 MG Oral Tablet	SCD	962601f8-7567-4afe-90a0-6df356f5a297	2
197391	baclofen 10 MG Oral Tablet	PSN	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1
197392	baclofen 20 MG Oral Tablet	PSN	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1
197391	baclofen 10 MG Oral Tablet	SCD	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1
197392	baclofen 20 MG Oral Tablet	SCD	c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0172-4096-60	00172409660	100 TABLET in 1 BOTTLE (0172-4096-60)	100 tablet	1988-07-21	0000-00-00	No	No	Current
0172-4096-80	00172409680	1000 TABLET in 1 BOTTLE (0172-4096-80)	1000 tablet	1988-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets USP Rx only	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	4
Baclofen Tablets USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-20	HUMAN PRESCRIPTION DRUG LABEL	27
Baclofen Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
BACLOFEN TABLETS USP	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	7
BACLOFEN	Direct_Rx \| Direct Rx	2023-02-03	HUMAN PRESCRIPTION DRUG LABEL	5
Baclofen Tablets USP Rx only	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	10
BACLOFEN TABLETS USP 4096 4097 Rx only	Unit Dose Services	2021-03-24	HUMAN PRESCRIPTION DRUG LABEL	6
Baclofen Tablets USP Rx only	Teva Pharmaceuticals USA, Inc.	2019-12-31	HUMAN PRESCRIPTION DRUG LABEL	19
BACLOFEN TABLETS USP	Physicians Total Care, Inc.	2014-02-13	HUMAN PRESCRIPTION DRUG LABEL	4
BACLOFEN TABLETS USP	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1
BACLOFEN TABLETS USP	H.J. Harkins Company, Inc. \| IVAX Pharmaceuticals, Inc.	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	2

Baclofen

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#