BACLOFEN

Product NDC: 80425-0478
Requested package NDC: 80425-0478-1
11-digit product format: 804250478
Labeler code: 80425
Product ID: 80425-0478_2cf6fc95-e6ff-0af3-e063-6294a90ac508
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA214374
Marketing category: ANDA
Marketing start: 2025-01-30
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
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
A214374-001	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05
A214374-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05
A214374-003	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214374-001	AB
A214374-002	AB
A214374-003	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 · 102 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	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214374-002	BACLOFEN	10MG	TABLET / ORAL	AB	2021-03-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214374-003	BACLOFEN	20MG	TABLET / ORAL	AB	2021-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214374-001	BACLOFEN	5MG	TABLET / ORAL	AB	2021-03-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A214374-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214374-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214374-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214374-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214374-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214374-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214374-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214374-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214374-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214374-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214374-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214374-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214374-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214374-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214374-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214374-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214374-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214374-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214374-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214374-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214374-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214374-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214374-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214374-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214374-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214374-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214374-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214374-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214374-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214374-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214374-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214374-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214374-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214374-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214374-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214374-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214374-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214374-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214374-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214374-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
2cf71f5f-6d46-7506-e063-6294a90a186f	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	SPL version
80425-0478-1	BACLOFEN	30 in 1 BOTTLE	TABLET	30	1
80425-0478-2	BACLOFEN	60 in 1 BOTTLE	TABLET	60	1
80425-0478-3	BACLOFEN	90 in 1 BOTTLE	TABLET	90	1
80425-0478-4	BACLOFEN	120 in 1 BOTTLE	TABLET	120	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0478-1	EA - Each	80425-0478	a3061446-53e2-452e-9c62-cd6d5a2cd80d	1	2025-03-04
80425-0478-2	EA - Each	80425-0478	53d819e7-51e2-4bbd-980e-976cd5a42095	1	2025-03-04
80425-0478-3	EA - Each	80425-0478	28f6c518-c4cd-4f0e-8106-1030f3b3fabe	1	2025-03-04
80425-0478-4	EA - Each	80425-0478	d8ff5408-5a1e-480e-b317-c22da0aa0605	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0478	BACLOFEN TABLET [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 4 package rows	20250201_2cf71f5f-6d46-7506-e063-6294a90a186f.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	NuCare Pharmaceuticals, Inc.	2517f71f-f452-1f56-e063-6394a90a6ef1	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	d20cc8b2-5236-4c87-b395-0acaaf7b62dd	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	5e479876-adfb-4590-ac10-3924ff7988b0	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	7df6e691-f1d5-441c-b5bb-a3867983e09f	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	c2e1d183-7061-459b-a631-206b06d12753	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ab3760cd-a84b-49ba-88e3-b9ea73c55f82	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2cf71f5f-6d46-7506-e063-6294a90a186f	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374 ndc (package): 80425-0478-1 ndc (product): 80425-0478 ndc11 (package): 80425047801
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	f9c6d75a-a956-47b6-a5a2-deaf9797e2b2	2024-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
Baclofen	BACLOFEN	Direct_rx	1bf59c3b-f8eb-972e-e063-6394a90aeccc	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	Rising Pharma Holdings, Inc.	6eb46715-d72b-473f-b984-90024033d4a0	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	96f9caa3-0d36-4d99-8c6f-0da5b0d03527	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214374 application number: ANDA214374

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
197392	baclofen 20 MG Oral Tablet	PSN	2cf71f5f-6d46-7506-e063-6294a90a186f	1
197392	baclofen 20 MG Oral Tablet	SCD	2cf71f5f-6d46-7506-e063-6294a90a186f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0478-1	80425047801	30 TABLET in 1 BOTTLE (80425-0478-1)	30 tablet	2025-01-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS, USP Rx only	Advanced Rx of Tennessee, LLC	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	1