Baclofen

Product NDC: 43063-864
11-digit product format: 430630864
Labeler code: 43063
Product ID: 43063-864_415c3642-f324-746e-e063-6294a90a7ae0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, 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.

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197391	Internal RxNorm lookup
197392	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
cfcf519f-5d15-431d-89c8-961a0c38ba60	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
43063-864-30	Baclofen	30 in 1 BOTTLE, PLASTIC	TABLET	30	26
43063-864-60	Baclofen	60 in 1 BOTTLE, PLASTIC	TABLET	60	26
43063-864-90	Baclofen	90 in 1 BOTTLE, PLASTIC	TABLET	90	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-864-30	EA - Each	43063-864	26735f87-d307-497a-be85-e7d76c0be162	1	2018-08-13
43063-864-60	EA - Each	43063-864	49fd2b5b-dce7-4f63-b8ff-6089788a2271	1	2018-08-13
43063-864-90	EA - Each	43063-864	7295c970-1136-438d-b83c-809ae240b03e	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-864	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	25	Current NDC, Legacy NDC, 3 package rows	20241017_cfcf519f-5d15-431d-89c8-961a0c38ba60.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 ndc (product): 43063-864
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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-864-30	43063086430	30 TABLET in 1 BOTTLE, PLASTIC (43063-864-30)	30 tablet	2018-06-26	0000-00-00	No	No	Current
43063-864-60	43063086460	60 TABLET in 1 BOTTLE, PLASTIC (43063-864-60)	60 tablet	2018-06-26	0000-00-00	No	No	Current
43063-864-90	43063086490	90 TABLET in 1 BOTTLE, PLASTIC (43063-864-90)	90 tablet	2018-06-26	0000-00-00	No	No	Current