Baclofen

Product NDC: 67046-1072
Requested package NDC: 67046-1072-3
11-digit product format: 670461072
Labeler code: 67046
Product ID: 67046-1072_5023daca-e46c-c225-e063-6394a90ab41b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA211659
Marketing category: ANDA
Marketing start: 2026-04-23
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 · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211659-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23
A211659-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23
A211659-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17
A211659-004	BACLOFEN	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211659-001	AB
A211659-002	AB
A211659-003	AB
A211659-004	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	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`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	A211659-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211659-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211659-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A211659-004	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 · 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	3c87e116-871d-46b8-897b-fc27a17b988d	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	AvPAK	c21095a9-17b1-555a-e053-2a95a90a51fd	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	AvPAK	bc9040d9-1c54-9d62-e053-2a95a90a6ae3	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Coupler LLC	5023c690-fd86-bb7d-e063-6394a90af6cd	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (package): 67046-1072-3 ndc (product): 67046-1072 ndc11 (package): 67046107203
Baclofen	BACLOFEN	A-S Medication Solutions	4f84b27a-725a-48e6-a58a-85bbb395f4ae	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	A-S Medication Solutions	5f6a86f9-9658-4210-a47c-62907edfd416	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	A-S Medication Solutions	975fda6d-d929-482b-8be7-60849026dbdd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	American Health Packaging	8b046ee6-28fc-4ab1-b543-414ad0103e5c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Bryant Ranch Prepack	5b92b0a6-ebba-4815-8b94-f2014674399b	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Zydus Lifesciences Limited	bb5c6faa-2933-44d1-8706-8302150be734	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Zydus Pharmaceuticals (USA) Inc.	cfc49176-8d01-4c39-9319-604dd087065c	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659

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
5023c690-fd86-bb7d-e063-6394a90af6cd	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	Strength	SPL version
67046-1072-3	Baclofen	30 in 1 BLISTER PACK	TABLET	30		1

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	5023c690-fd86-bb7d-e063-6394a90af6cd	1
197391	baclofen 10 MG Oral Tablet	SCD	5023c690-fd86-bb7d-e063-6394a90af6cd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1072-3	67046107203	30 TABLET in 1 BLISTER PACK (67046-1072-3)	30 tablet	2026-04-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS USP Rx only	Coupler LLC \| Zydus Lifesciences Global FZE	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	1