BACLOFEN

Product NDC: 0615-8466
11-digit product format: 006158466
Labeler code: 0615
Product ID: 0615-8466_9c2e25e4-823f-4ac2-82f4-674049807af5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA209102
Marketing category: ANDA
Marketing start: 2018-04-01
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: 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
A209102-001	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2017-11-28
A209102-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2017-11-28
A209102-003	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2017-11-28
A209102-004	BACLOFEN	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209102-001	AB
A209102-002	AB
A209102-003	AB
A209102-004	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 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`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	A209102-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209102-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209102-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209102-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209102-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209102-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209102-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

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 · 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
2927228a-7a3e-4e1d-ab5f-4407b00f6899	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
0615-8466-05	BACLOFEN	15 in 1 BLISTER PACK	TABLET	15		1
0615-8466-39	BACLOFEN	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8466	BACLOFEN TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	1	Current NDC, 2 package rows	20230602_2927228a-7a3e-4e1d-ab5f-4407b00f6899.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Redpharm Drug	53df4b4b-842e-9e3a-e063-6394a90a8a3d	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	e017a001-8cb1-4dd8-960e-c6d74005f57f	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ac9b720f-b755-49f1-9850-efb26feadaeb	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	ee59a379-17d5-487f-b72f-a53e74744a70	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	91175128-8285-4d04-89a9-219781be9260	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	16266972-843e-4ea5-be1f-fb1b1588a5dc	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	0a1d09ac-94d5-45ef-92cc-bc261c2b2d75	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Major Pharmaceuticals	46f84504-ffc4-4be5-9598-c20a3f4210f4	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Advagen Pharma Limited	04dac0f6-cc6c-4959-9bca-a6e4a99690f3	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	00c6c924-ddfd-4a75-afd7-f6561ff9abbc	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	459ec5f5-4f99-e917-e063-6294a90a23cd	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	SOLA Pharmaceuticals, LLC	7b308b35-8c08-458d-860e-c78d057e8260	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Proficient Rx LP	0680301a-1649-46c4-b74e-ab03967945d0	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	5cba5255-e5ad-48fd-8385-60e9ea6b6407	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	4e2cd27d-91c7-4f15-96cc-3971769dbeaa	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	35bccefe-8d2e-85b5-e063-6394a90a58ca	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	A-S Medication Solutions	eb690a49-b87b-433f-9afe-2966406fe00e	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	A-S Medication Solutions	af0ade6c-9dd4-42d3-879e-4201fbe585ee	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Proficient Rx LP	0243dd97-1d40-48f7-8853-76e046c605f2	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
Baclofen	BACLOFEN	Direct_Rx	020632f4-5e8a-f4a0-e063-6294a90a6301	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102

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	2927228a-7a3e-4e1d-ab5f-4407b00f6899	1
197392	baclofen 20 MG Oral Tablet	PSN	2927228a-7a3e-4e1d-ab5f-4407b00f6899	1
197391	baclofen 10 MG Oral Tablet	SCD	2927228a-7a3e-4e1d-ab5f-4407b00f6899	1
197392	baclofen 20 MG Oral Tablet	SCD	2927228a-7a3e-4e1d-ab5f-4407b00f6899	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8466-05	00615846605	15 TABLET in 1 BLISTER PACK (0615-8466-05)	15 tablet	2023-05-08	No	No	Current
0615-8466-39	00615846639	30 TABLET in 1 BLISTER PACK (0615-8466-39)	30 tablet	2023-05-08	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	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL	1