Baclofen

Product NDC: 71335-0344
Requested package NDC: 71335-0344-4
11-digit product format: 713350344
Labeler code: 71335
Product ID: 71335-0344_8858eea4-a4da-4add-8f5e-bb264c8e85e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078220
Marketing category: ANDA
Marketing start: 2007-07-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0344	71335-0344-4	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

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
fded79a4-c354-448d-96dd-6dc69c46a013	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
71335-0344-0	Baclofen	112 in 1 BOTTLE, PLASTIC	TABLET	112	104
71335-0344-1	Baclofen	30 in 1 BOTTLE, PLASTIC	TABLET	30	104
71335-0344-2	Baclofen	120 in 1 BOTTLE, PLASTIC	TABLET	120	104
71335-0344-3	Baclofen	20 in 1 BOTTLE, PLASTIC	TABLET	20	104
71335-0344-4	Baclofen	60 in 1 BOTTLE, PLASTIC	TABLET	60	104
71335-0344-5	Baclofen	100 in 1 BOTTLE, PLASTIC	TABLET	100	104
71335-0344-6	Baclofen	56 in 1 BOTTLE, PLASTIC	TABLET	56	104
71335-0344-7	Baclofen	90 in 1 BOTTLE, PLASTIC	TABLET	90	104
71335-0344-8	Baclofen	140 in 1 BOTTLE, PLASTIC	TABLET	140	104
71335-0344-9	Baclofen	84 in 1 BOTTLE, PLASTIC	TABLET	84	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0344-0	EA - Each	71335-0344	889fe0b4-f6ea-40e2-a615-040ac9023b43	1	2018-01-12
71335-0344-1	EA - Each	71335-0344	ef0efbd2-0e58-4690-88e5-eef710795439	1	2018-01-12
71335-0344-2	EA - Each	71335-0344	98302844-2556-4d59-bb2b-5b9741313c38	1	2018-01-12
71335-0344-3	EA - Each	71335-0344	1db56618-639d-419b-82bd-410e3206aaf8	1	2018-01-12
71335-0344-4	EA - Each	71335-0344	80c10dcb-7b2e-411e-bb83-8abfeddab370	1	2018-01-12
71335-0344-5	EA - Each	71335-0344	eb10b7f3-c488-4eed-8ef2-394ea611feb8	1	2018-01-12
71335-0344-6	EA - Each	71335-0344	46c907e4-3054-4fa8-b6ce-b6d55ee19279	1	2018-01-12
71335-0344-7	EA - Each	71335-0344	9794d90e-8f06-47ef-b7a6-fc060e65ca79	1	2018-01-12
71335-0344-8	EA - Each	71335-0344	2323a699-191c-4007-a9c9-b756101f4184	1	2018-01-12
71335-0344-9	EA - Each	71335-0344	2b13d4d3-64ef-4241-9d7a-789c68ddf325	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0344	BACLOFEN TABLET [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 10 package rows	20240823_fded79a4-c354-448d-96dd-6dc69c46a013.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	Cardinal Health 107, LLC	2278954a-7605-426a-ae85-1bf0a3117420	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Preferred Pharmaceuticals, Inc.	58416ceb-994f-4571-afbd-c2171823f528	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Major Pharmaceuticals	ae732bdc-5178-4565-8219-d1787a5211a6	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	cfcf519f-5d15-431d-89c8-961a0c38ba60	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	402a0a2b-95a6-4d22-bedf-826e1f1cd2c3	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	54bea140-c537-44a2-8d1d-bfb20471f4d8	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	12d57610-8c70-4729-b358-56525613a29d	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Bryant Ranch Prepack	fded79a4-c354-448d-96dd-6dc69c46a013	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220 ndc (package): 71335-0344-4 ndc (product): 71335-0344 ndc11 (package): 71335034404
Baclofen	BACLOFEN	Lannett Company, Inc.	f84f3f4c-17e6-43f1-9600-63b0b175837b	2021-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	d9e5a8b9-1524-41b4-942f-f95015dd17f9	2020-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078220 application number: ANDA078220

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	fded79a4-c354-448d-96dd-6dc69c46a013	104
197391	baclofen 10 MG Oral Tablet	SCD	fded79a4-c354-448d-96dd-6dc69c46a013	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0344-4	71335034404	60 TABLET in 1 BOTTLE, PLASTIC (71335-0344-4)	60 tablet	2022-02-09	0000-00-00	No	No	Current