Baclofen

Product NDC: 50090-0564
Requested package NDC: 50090-0564-3
11-digit product format: 500900564
Labeler code: 50090
Product ID: 50090-0564_cee85db5-a84f-48c3-9c5c-e2a4b8af718d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA072234
Marketing category: ANDA
Marketing start: 1988-07-21
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0564	50090-0564-3	I	Inactivated by FDA		2026-08-11

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A072234-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072234-001	AB	1	`cb3db0bc1861…`

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
50090-0564-0	2023-01-30	C162847	48780-1	f386c649-c737-0266-e053-dadaa90a7c1a	Baclofen Tablets USP Rx only
50090-0564-1	2023-01-30	C162847	48780-1	f386c649-c737-0266-e053-dadaa90a7c1a	Baclofen Tablets USP Rx only
50090-0564-3	2023-01-30	C162847	48780-1	f386c649-c737-0266-e053-dadaa90a7c1a	Baclofen Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0564-0	Baclofen	60 in 1 BOTTLE	TABLET	60	10
50090-0564-1	Baclofen	30 in 1 BOTTLE	TABLET	30	10
50090-0564-3	Baclofen	90 in 1 BOTTLE	TABLET	90	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0564	BACLOFEN TABLET [A-S MEDICATION SOLUTIONS]	10	Legacy NDC, 3 package rows	20210616_36f8b9c9-4e9d-41e4-b889-05cb948c6718.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
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	36f8b9c9-4e9d-41e4-b889-05cb948c6718	10
197391	baclofen 10 MG Oral Tablet	SCD	36f8b9c9-4e9d-41e4-b889-05cb948c6718	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0564-3	50090056403	90 TABLET in 1 BOTTLE (50090-0564-3)	90 tablet	2016-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baclofen Tablets USP Rx only	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	10