Baclofen

Product NDC: 0615-8518
Requested package NDC: 0615-8518-05
11-digit product format: 006158518
Labeler code: 0615
Product ID: 0615-8518_8c1dfdbe-e30f-436d-882e-8b4c5f8ca29a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA215885
Marketing category: ANDA
Marketing start: 2022-01-26
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 · 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…`

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 · 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
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 ndc (package): 0615-8518-05 ndc (product): 0615-8518 ndc11 (package): 00615851805

Additional Listing Data#

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

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
ea4ad5c5-207c-4a68-8e6e-4ff101777e5c	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
0615-8518-05	Baclofen	15 in 1 BLISTER PACK	TABLET	15		2
0615-8518-39	Baclofen	30 in 1 BLISTER PACK	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8518	BACLOFEN TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	2	Current NDC, 2 package rows	20241006_ea4ad5c5-207c-4a68-8e6e-4ff101777e5c.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
430902	baclofen 5 MG Oral Tablet	PSN	ea4ad5c5-207c-4a68-8e6e-4ff101777e5c	2
430902	baclofen 5 MG Oral Tablet	SCD	ea4ad5c5-207c-4a68-8e6e-4ff101777e5c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8518-05	00615851805	15 TABLET in 1 BLISTER PACK (0615-8518-05)	15 tablet	2024-08-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets, USP Rx only	NCS HealthCare of KY, LLC dba Vangard Labs	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	2