BACLOFEN

Product NDC: 61919-093
11-digit product format: 619190093
Labeler code: 61919
Product ID: 61919-093_e9e76e2b-7d09-8c57-e053-2a95a90a8b3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078220
Marketing category: ANDA
Marketing start: 2019-07-29
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-093		I	Inactivated by FDA	2026-10-05
excluded product	product	61919-093		I	Inactivated by FDA	2026-10-05
excluded package	package	61919-093	61919-093-07	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-093	61919-093-14	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-093	61919-093-30	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-093	61919-093-72	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-093	61919-093-60	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-093	61919-093-86	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-093	61919-093-90	I	Inactivated by FDA	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 2 · 90 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-093-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-093-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-093-72	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-093-07	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-093-14	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-093-86	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-093-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-093-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-093-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-093-72	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-093-07	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-093-14	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-093-86	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-093-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-093-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-093-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-093-72	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-093-07	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-093-14	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-093-86	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-093-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-093-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-093-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-093-72	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-093-07	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-093-14	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-093-86	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-093-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-093-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-093-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-093-72	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-093-07	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-093-14	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-093-86	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-093-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-093-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-093-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-093-72	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-093-07	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-093-14	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-093-86	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-093-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-093-07	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-093-86	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-093-90	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-093-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`

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.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-093-07	2025-01-30	2cef2736-746a-d83d-e063-dadaa90ab31f	BACLOFEN
61919-093-14	2025-01-30	2cef2736-746a-d83d-e063-dadaa90ab31f	BACLOFEN
61919-093-30	2025-01-30	2cef2736-746a-d83d-e063-dadaa90ab31f	BACLOFEN
61919-093-60	2025-01-30	9d75b9d0-d969-f424-e053-dadaa90a57ce	BACLOFEN
61919-093-72	2025-01-30	2cef2736-746a-d83d-e063-dadaa90ab31f	BACLOFEN
61919-093-86	2025-01-30	9d75b9d0-d969-f424-e053-dadaa90a57ce	BACLOFEN
61919-093-90	2025-01-30	9d75b9d0-d969-f424-e053-dadaa90a57ce	BACLOFEN
61919-093-30	2020-12-14	9d75b9d0-d969-f424-e053-dadaa90a57ce	BACLOFEN
61919-093-86	2020-12-14	9d75b9d0-d969-f424-e053-dadaa90a57ce	BACLOFEN
61919-093-30	2020-01-31	9d75b9d0-d969-f424-e053-dadaa90a57ce	BACLOFEN
61919-093-86	2020-01-31	9d75b9d0-d969-f424-e053-dadaa90a57ce	BACLOFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-093-07	BACLOFEN	7 in 1 BOTTLE	TABLET	7	6
61919-093-14	BACLOFEN	14 in 1 BOTTLE	TABLET	14	6
61919-093-30	BACLOFEN	30 in 1 BOTTLE	TABLET	30	6
61919-093-60	BACLOFEN	60 in 1 BOTTLE	TABLET	60	6
61919-093-72	BACLOFEN	120 in 1 BOTTLE	TABLET	120	6
61919-093-86	BACLOFEN	270 in 1 BOTTLE	TABLET	270	6
61919-093-90	BACLOFEN	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-093-07	EA - Each	61919-093	df1c97db-877b-4dfe-a6f8-61ac4f3609be	1	2023-04-07
61919-093-14	EA - Each	61919-093	55d1986f-f9c6-4579-b0b3-85739c962070	1	2023-04-07
61919-093-30	EA - Each	61919-093	9156cb79-67f9-4c7a-bdd7-d29e5a640973	1	2015-10-02
61919-093-60	EA - Each	61919-093	db26dde6-b322-46d8-80aa-6e6ea35984e4	1	2015-10-02
61919-093-72	EA - Each	61919-093	5ecae864-e904-46ec-85bc-79f33bb85837	1	2019-08-06
61919-093-86	EA - Each	61919-093	ed915d28-89d6-4531-87d0-db514bcdb990	1	2019-09-05
61919-093-90	EA - Each	61919-093	dca01666-46e7-41f8-ae3a-b0b2731be407	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-093	BACLOFEN TABLET [DIRECT RX]	6	Legacy NDC, 3 package rows	20221001_b6309f7f-e8ed-4233-b160-3838ff2bab13.zip
61919-093	BACLOFEN TABLET [DIRECT_RX]	6	Legacy NDC, 4 package rows	20230929_8ed7ca43-28e3-ef10-e053-2995a90af4a9.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
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	8ed7ca43-28e3-ef10-e053-2995a90af4a9	6
197391	baclofen 10 MG Oral Tablet	PSN	b6309f7f-e8ed-4233-b160-3838ff2bab13	6
197391	baclofen 10 MG Oral Tablet	SCD	8ed7ca43-28e3-ef10-e053-2995a90af4a9	6
197391	baclofen 10 MG Oral Tablet	SCD	b6309f7f-e8ed-4233-b160-3838ff2bab13	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-093-07	61919009307	7 in 1 BOTTLE						Historical
61919-093-14	61919009314	14 in 1 BOTTLE						Historical
61919-093-30	61919009330	30 BOTTLE in 1 BOTTLE (61919-093-30) > 60 BOTTLE in 1 BOTTLE (61919-093-60) > 90 TABLET in 1 BOTTLE (61919-093-90)	30 bottle	2015-01-20	0000-00-00	No	No	Current
61919-093-60	61919009360	60 TABLET in 1 BOTTLE (61919-093-60)	60 tablet	2014-01-01	0000-00-00	No	No	Current
61919-093-72	61919009372	120 TABLET in 1 BOTTLE (61919-093-72)	120 tablet	2019-07-29	0000-00-00	No	No	Current
61919-093-86	61919009386	270 TABLET in 1 BOTTLE (61919-093-86)	270 tablet	2014-01-01	0000-00-00	No	No	Current
61919-093-90	61919009390	90 TABLET in 1 BOTTLE (61919-093-90)	90 tablet	2014-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN	Direct_Rx	2023-09-28	HUMAN PRESCRIPTION DRUG LABEL	6
BACLOFEN	DIRECT RX	2022-09-27	HUMAN PRESCRIPTION DRUG LABEL	6