Baclofen

Product NDC: 0832-1054
11-digit product format: 008321054
Labeler code: 0832
Product ID: 0832-1054_45af8926-ad18-a93a-e063-6294a90a1dca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA074584
Marketing category: ANDA
Marketing start: 2010-10-20
Marketing end: 2026-10-31
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
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074584-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		1996-08-19
A074584-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB		1996-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074584-001	AB
A074584-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074584-001	BACLOFEN	10MG	TABLET / ORAL	AB	1996-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074584-002	BACLOFEN	20MG	TABLET / ORAL	AB	1996-08-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074584-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074584-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074584-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074584-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074584-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074584-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074584-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074584-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074584-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074584-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074584-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074584-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074584-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074584-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074584-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074584-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074584-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074584-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074584-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074584-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074584-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074584-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074584-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074584-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074584-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074584-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074584-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074584-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074584-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen

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
b2747a9d-5fca-4657-9e4b-4112607f30d8	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
0832-1054-10	Baclofen	1000 in 1 BOTTLE	TABLET	1000	8
0832-1054-11	Baclofen	100 in 1 BOTTLE	TABLET	100	8
0832-1054-15	Baclofen	500 in 1 BOTTLE	TABLET	500	8
0832-1054-90	Baclofen	90 in 1 BOTTLE	TABLET	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-1054-10	EA - Each	0832-1054	74da9a49-4315-4383-97f9-3bc61f287d90	1	2018-03-08
0832-1054-11	EA - Each	0832-1054	78815c52-0d03-4693-b9af-3bcf5413c7df	1	2018-03-08
0832-1054-15	EA - Each	0832-1054	15ee48a0-e805-451d-883f-7d29adc5ac67	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-1054	BACLOFEN TABLET [UPSHER-SMITH LABORATORIES, LLC]	6	Current NDC, Legacy NDC, 4 package rows	20230408_b2747a9d-5fca-4657-9e4b-4112607f30d8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Upsher-Smith Laboratories, LLC	b2747a9d-5fca-4657-9e4b-4112607f30d8	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074584 application number: ANDA074584 ndc (product): 0832-1054
Baclofen	BACLOFEN	A-S Medication Solutions	e163e7dc-45a5-43c2-b13d-a4453f2c360c	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074584 application number: ANDA074584
Baclofen	BACLOFEN	A-S Medication Solutions	081d478a-2f3f-456e-bcca-00487589da6f	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074584 application number: ANDA074584

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	b2747a9d-5fca-4657-9e4b-4112607f30d8	8
197392	baclofen 20 MG Oral Tablet	PSN	b2747a9d-5fca-4657-9e4b-4112607f30d8	8
197391	baclofen 10 MG Oral Tablet	SCD	b2747a9d-5fca-4657-9e4b-4112607f30d8	8
197392	baclofen 20 MG Oral Tablet	SCD	b2747a9d-5fca-4657-9e4b-4112607f30d8	8
197391	baclofen 10 MG Oral Tablet	PSN	081d478a-2f3f-456e-bcca-00487589da6f	1
197391	baclofen 10 MG Oral Tablet	PSN	e163e7dc-45a5-43c2-b13d-a4453f2c360c	1
197391	baclofen 10 MG Oral Tablet	SCD	081d478a-2f3f-456e-bcca-00487589da6f	1
197391	baclofen 10 MG Oral Tablet	SCD	e163e7dc-45a5-43c2-b13d-a4453f2c360c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0832-1054-10	00832105410	1000 TABLET in 1 BOTTLE (0832-1054-10)	1000 tablet	2018-02-27	2026-10-31	No	No	Current
0832-1054-11	00832105411	100 TABLET in 1 BOTTLE (0832-1054-11)	100 tablet	2018-02-27	2026-10-31	No	No	Current
0832-1054-15	00832105415	500 TABLET in 1 BOTTLE (0832-1054-15)	500 tablet	2018-02-27	2026-10-31	No	No	Current
0832-1054-90	00832105490	90 TABLET in 1 BOTTLE (0832-1054-90)	90 tablet	2018-02-27	2026-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS, USP	Upsher-Smith Laboratories, LLC \| Bora Pharmaceuticals, Inc	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	8
BACLOFEN TABLETS, USP	REMEDYREPACK INC.	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	2
BACLOFEN TABLETS, USP	A-S Medication Solutions	2023-12-05	HUMAN PRESCRIPTION DRUG LABEL	1
BACLOFEN TABLETS, USP	A-S Medication Solutions	2023-12-05	HUMAN PRESCRIPTION DRUG LABEL	1