Baclofen

Product NDC: 50268-105
11-digit product format: 502680105
Labeler code: 50268
Product ID: 50268-105_2b489a19-55e7-8503-e063-6294a90aa6e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA211659
Marketing category: ANDA
Marketing start: 2021-05-11
Substance: BACLOFEN
Active strength: 5 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 · 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.

Product history page 1 of 4 · 135 observed 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
2026-02-19 14:30 UTC	2026-02	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	5 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
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
c21095a9-17b1-555a-e053-2a95a90a51fd	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
50268-105-11	Baclofen	1 in 1 BLISTER PACK	TABLET	1		4
50268-105-15	Baclofen	50 in 1 BOX	TABLET	50		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-105-11	EA - Each	50268-105	3bddb494-2d88-4648-ad3c-f9c02f05cd47	1	2021-06-02
50268-105-15	EA - Each	50268-105	1f6d7548-eae2-477f-b7c9-546f0be7469e	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-105	BACLOFEN TABLET [AVPAK]	4	Current NDC, Legacy NDC, 2 package rows	20250112_c21095a9-17b1-555a-e053-2a95a90a51fd.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	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 ndc (product): 50268-105
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
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

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
430902	baclofen 5 MG Oral Tablet	PSN	c21095a9-17b1-555a-e053-2a95a90a51fd	4
430902	baclofen 5 MG Oral Tablet	SCD	c21095a9-17b1-555a-e053-2a95a90a51fd	4
430902	baclofen 5 MG Oral Tablet	PSN	3c87e116-871d-46b8-897b-fc27a17b988d	3
430902	baclofen 5 MG Oral Tablet	SCD	3c87e116-871d-46b8-897b-fc27a17b988d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-105-11	50268010511	1 in 1 BLISTER PACK						Historical
50268-105-15	50268010515	50 BLISTER PACK in 1 BOX (50268-105-15) / 1 TABLET in 1 BLISTER PACK (50268-105-11)	50 blister pack	2021-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets USP Rx only	Cardinal Health 107, LLC	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	4
Baclofen Tablets USP Rx only	AvPAK	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	5