Baclofen

Product NDC: 21695-014
11-digit product format: 216950014
Labeler code: 21695
Product ID: 21695-014_14878615-b39c-477e-b33d-dd9753c7a3cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA072824
Marketing category: ANDA
Marketing start: 2004-07-01
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: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-014		I	Inactivated by FDA	2026-10-15
excluded package	package	21695-014	21695-014-42	I	Inactivated by FDA	2026-10-15
excluded package	package	21695-014	21695-014-72	I	Inactivated by FDA	2026-10-15
excluded package	package	21695-014	21695-014-90	I	Inactivated by FDA	2026-10-15

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 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-014-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-014-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-014-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-014-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-014-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-014-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-014-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-014-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-014-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-014-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-014-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-014-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-014-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-014-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-014-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-014-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-014-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-014-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-014-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-014-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-014-72	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-014-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-014-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-014-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-014-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-014-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-014-72	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-014-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-014-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-014-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-014-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-014-42	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-014-72	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-014-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-014-42	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-014-72	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-014-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-014-42	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-014-72	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-014-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-014-42	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-014-72	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-014-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-014-42	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-014-72	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A072824-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL			1991-09-18

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072824-001	BACLOFEN	10MG	TABLET / ORAL	1991-09-18	`3a93d1ddd44b…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-014-42	2019-09-24	C162847	48780-1	934fe258-4c6e-48b1-e053-8cdaa90a720a	Baclofen Tablets USP 10mg & 20mg
21695-014-72	2019-09-24	C162847	48780-1	934fe258-4c6e-48b1-e053-8cdaa90a720a	Baclofen Tablets USP 10mg & 20mg
21695-014-90	2019-09-24	C162847	48780-1	934fe258-4c6e-48b1-e053-8cdaa90a720a	Baclofen Tablets USP 10mg & 20mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-014-30	Baclofen	30 in 1 BOTTLE	TABLET	30	1
21695-014-42	Baclofen	42 in 1 BOTTLE	TABLET	42	1
21695-014-60	Baclofen	60 in 1 BOTTLE	TABLET	60	1
21695-014-72	Baclofen	120 in 1 BOTTLE	TABLET	120	1
21695-014-90	Baclofen	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-014-30	EA - Each	21695-014	045b5479-8a48-4d8c-9230-f5d2a183b569	1	2012-07-24
21695-014-60	EA - Each	21695-014	f974850f-d5fd-43d0-8ba4-4c7e7a277577	1	2012-07-24
21695-014-72	EA - Each	21695-014	67d2f2c6-d0bc-41c7-872b-eb0966b54255	1	2012-07-24
21695-014-90	EA - Each	21695-014	10ba6395-b45c-47ec-8f19-96e039588df3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-014	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 5 package rows	20100329_d88886cc-62c0-44dd-8a3f-cac601832d8e.zip

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	d88886cc-62c0-44dd-8a3f-cac601832d8e	1
197392	baclofen 20 MG Oral Tablet	PSN	d88886cc-62c0-44dd-8a3f-cac601832d8e	1
197391	baclofen 10 MG Oral Tablet	SCD	d88886cc-62c0-44dd-8a3f-cac601832d8e	1
197392	baclofen 20 MG Oral Tablet	SCD	d88886cc-62c0-44dd-8a3f-cac601832d8e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-014-30	21695001430	30 in 1 BOTTLE	Historical
21695-014-42	21695001442	42 in 1 BOTTLE	Historical
21695-014-60	21695001460	60 in 1 BOTTLE	Historical
21695-014-72	21695001472	120 in 1 BOTTLE	Historical
21695-014-90	21695001490	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets USP 10mg & 20mg	Rebel Distributors Corp.	2009-12-01	HUMAN PRESCRIPTION DRUG LABEL	1