Baclofen

Product NDC: 82868-013
Requested package NDC: 82868-013-60
11-digit product format: 828680013
Labeler code: 82868
Product ID: 82868-013_46dc934b-8b1e-a00e-e063-6394a90a5d4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA072234
Marketing category: ANDA
Marketing start: 2023-09-27
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072234-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		1988-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072234-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A072234-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072234-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072234-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072234-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072234-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072234-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072234-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072234-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072234-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072234-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072234-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072234-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072234-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072234-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072234-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072234-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072234-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072234-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072234-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072234-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072234-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072234-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072234-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072234-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072234-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072234-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072234-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072234-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072234-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072234-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072234-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072234-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072234-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072234-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072234-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072234-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072234-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072234-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072234-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072234-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 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
06bcfb08-2ada-f803-e063-6394a90a826b	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
82868-013-30	Baclofen	30 in 1 BOTTLE, PLASTIC	TABLET	30		4
82868-013-60	Baclofen	60 in 1 BOTTLE, PLASTIC	TABLET	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82868-013	BACLOFEN TABLET [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, 2 package rows	20240110_06bcfb08-2ada-f803-e063-6394a90a826b.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Northwind Health Company, LLC	06bcfb08-2ada-f803-e063-6394a90a826b	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (package): 82868-013-60 ndc (product): 82868-013 ndc11 (package): 82868001360
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	95755a7b-4a9f-45ea-a381-d3f661150efe	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c4164-e607-2e27-e053-2a95a90ad7db	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	Proficient Rx LP	b981eb16-a195-41da-a186-3e91b63b2def	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	Teva Pharmaceuticals USA, Inc.	5648c772-50cb-4961-996e-e68a8eb699ea	2019-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234

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	06bcfb08-2ada-f803-e063-6394a90a826b	4
197391	baclofen 10 MG Oral Tablet	SCD	06bcfb08-2ada-f803-e063-6394a90a826b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82868-013-60	82868001360	60 TABLET in 1 BOTTLE, PLASTIC (82868-013-60)	60 tablet	2023-09-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets USP Rx only	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	4