Baclofen

Product NDC: 55154-7876
11-digit product format: 551547876
Labeler code: 55154
Product ID: 55154-7876_ee805abe-f897-47f7-a472-9630a160d0c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA077241
Marketing category: ANDA
Marketing start: 2015-07-15
Marketing end: 2026-12-31
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
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.

Product history page 1 of 3 · 115 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	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 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	A077241-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077241-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077241-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077241-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077241-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen

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
2278954a-7605-426a-ae85-1bf0a3117420	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
55154-7876-0	Baclofen	1 in 1 BLISTER PACK	TABLET	1		11
55154-7876-0	Baclofen	10 in 1 BAG	TABLET	10		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-7876	BACLOFEN TABLET [CARDINAL HEALTH 107, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20241025_2278954a-7605-426a-ae85-1bf0a3117420.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 · 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 ndc (product): 55154-7876
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
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

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	2278954a-7605-426a-ae85-1bf0a3117420	11
197392	baclofen 20 MG Oral Tablet	PSN	2278954a-7605-426a-ae85-1bf0a3117420	11
197391	baclofen 10 MG Oral Tablet	SCD	2278954a-7605-426a-ae85-1bf0a3117420	11
197392	baclofen 20 MG Oral Tablet	SCD	2278954a-7605-426a-ae85-1bf0a3117420	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-7876-0	55154787600	10 BLISTER PACK in 1 BAG (55154-7876-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2015-07-15	2026-12-31	No	No	Current