Baclofen

Product NDC: 43063-865
11-digit product format: 430630865
Labeler code: 43063
Product ID: 43063-865_415c3642-f324-746e-e063-6294a90a7ae0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA077241
Marketing category: ANDA
Marketing start: 2005-12-20
Substance: BACLOFEN
Active strength: 20 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 · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077241-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20
A077241-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06
A077241-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077241-001	AB
A077241-002	AB
A077241-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077241-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077241-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077241-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 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): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Major Pharmaceuticals	ae732bdc-5178-4565-8219-d1787a5211a6	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	cfcf519f-5d15-431d-89c8-961a0c38ba60	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241 ndc (product): 43063-865
Baclofen	BACLOFEN	Marlex Pharmaceuticals Inc	1b0f50c8-62e3-414d-96d3-5fd16e8043ab	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	b4f2f888-979a-6f54-e053-2a95a90a95a3	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Chartwell RX, LLC	2a75db96-590a-43cf-aefb-3bbcb287dbf0	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	7f27f935-b1fa-4494-9014-7f62c59bb8e3	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	b4506087-be24-4e76-9fb8-b07805137072	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	c582972d-22ef-4326-b37f-adf2ca0b1875	2023-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	58816b46-28a5-48e2-b89d-98df65939386	2023-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	9110b1cb-8604-4824-9337-84b08d41dd3c	2023-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Lannett Company, Inc.	f84f3f4c-17e6-43f1-9600-63b0b175837b	2021-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Proficient Rx LP	924a01fb-0ed0-4f73-9304-d6c5b9961d66	2020-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	20 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
43063-865-30	Baclofen	30 in 1 BOTTLE, PLASTIC	TABLET	30	26
43063-865-60	Baclofen	60 in 1 BOTTLE, PLASTIC	TABLET	60	26
43063-865-90	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
43063-865-30	EA - Each	43063-865	bc63a36d-b935-4664-b290-8a4120027b27	1	2018-08-13
43063-865-60	EA - Each	43063-865	318dd816-5939-48a0-87a7-43d5e0eb9056	1	2018-08-13
43063-865-90	EA - Each	43063-865	ed38416f-947a-4035-adbb-7352a0453d92	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-865	BACLOFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	25	Current NDC, Legacy NDC, 3 package rows	20241017_cfcf519f-5d15-431d-89c8-961a0c38ba60.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	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
43063-865-30	43063086530	30 TABLET in 1 BOTTLE, PLASTIC (43063-865-30)	30 tablet	2018-06-26	0000-00-00	No	No	Current
43063-865-60	43063086560	60 TABLET in 1 BOTTLE, PLASTIC (43063-865-60)	60 tablet	2018-06-26	0000-00-00	No	No	Current
43063-865-90	43063086590	90 TABLET in 1 BOTTLE, PLASTIC (43063-865-90)	90 tablet	2018-06-26	0000-00-00	No	No	Current