BACLOFEN

Product NDC: 55154-0198
11-digit product format: 551540198
Labeler code: 55154
Product ID: 55154-0198_ae6c8772-e83b-4d39-884c-2fb324baea37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA215885
Marketing category: ANDA
Marketing start: 2026-03-23
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215885-001	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25
A215885-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25
A215885-003	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215885-001	AB
A215885-002	AB
A215885-003	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 · 96 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	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-002	BACLOFEN	10MG	TABLET / ORAL	AB	2022-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-003	BACLOFEN	20MG	TABLET / ORAL	AB	2022-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215885-001	BACLOFEN	5MG	TABLET / ORAL	AB	2022-01-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 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	A215885-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215885-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215885-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215885-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215885-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215885-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215885-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215885-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215885-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215885-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215885-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215885-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215885-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215885-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215885-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215885-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215885-001	AB	1	`8072bd15b7f6…`

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
a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c	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
55154-0198-0	BACLOFEN	1 in 1 BAG	TABLET	1		2
55154-0198-0	BACLOFEN	10 in 1 BLISTER PACK	TABLET	10		2

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	REMEDYREPACK INC.	ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	Golden State Medical Supply, Inc.	32336e92-89a4-7d7f-e063-6394a90ae924	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
BACLOFEN	BACLOFEN	Cardinal Health 107, LLC	a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885 ndc (product): 55154-0198
Baclofen	BACLOFEN	Lifestar Pharma LLC	f9dd1b55-2984-446a-8146-2ab0f5211e15	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
BACLOFEN	BACLOFEN	Major Pharmaceuticals	f328296e-0713-4acb-bcb5-c10d7838d380	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	39ad22ca-f034-f605-e063-6294a90a08e4	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	3981db3e-672c-1634-e063-6294a90a4cd1	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885
Baclofen	BACLOFEN	NCS HealthCare of KY, LLC dba Vangard Labs	ea4ad5c5-207c-4a68-8e6e-4ff101777e5c	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215885 application number: ANDA215885

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	a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c	2
197391	baclofen 10 MG Oral Tablet	SCD	a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-0198-0	55154019800	1 BLISTER PACK in 1 BAG (55154-0198-0) / 10 TABLET in 1 BLISTER PACK	1 blister pack	2026-03-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	2