Baclofen

Product NDC: 52959-677
11-digit product format: 529590677
Labeler code: 52959
Product ID: 52959-677_0d3ec116-a621-4f15-bc56-c63487a319bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA072235
Marketing category: ANDA
Marketing start: 2010-07-15
Marketing end: 0000-00-00
Substance: BACLOFEN
Active strength: 20 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-677		I	Inactivated by FDA	2026-08-10
excluded package	package	52959-677	52959-677-02	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-677	52959-677-10	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-677	52959-677-30	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-677	52959-677-45	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-677	52959-677-60	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-677	52959-677-90	I	Inactivated by FDA	2026-08-10

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 3 · 154 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	52959-677-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-677-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-677-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-677-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-677-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-677-90	`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	52959-677-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-677-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-677-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-677-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-677-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-677-90	`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	52959-677-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-677-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-677-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-677-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-677-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-677-90	`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	52959-677-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-677-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-677-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-677-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-677-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-677-90	`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	52959-677-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-677-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-677-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-677-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-677-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-677-90	`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	52959-677-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-677-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-677-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-677-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-677-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-677-90	`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	52959-677-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-677-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-677-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-677-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-677-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-677-90	`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	52959-677-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-677-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-677-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-677-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-677-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-677-90	`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	52959-677-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-677-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-677-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
A072235-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	RS	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
A072235-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	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	A072235-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072235-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072235-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072235-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072235-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072235-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072235-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072235-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072235-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072235-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072235-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072235-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072235-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072235-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072235-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072235-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072235-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072235-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072235-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072235-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072235-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072235-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072235-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072235-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072235-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072235-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072235-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072235-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072235-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072235-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072235-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072235-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072235-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072235-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072235-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072235-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072235-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072235-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072235-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072235-001	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, Related label table
NDC	Related label
52959-677-02	BACLOFEN TABLETS USP
52959-677-10	BACLOFEN TABLETS USP
52959-677-30	BACLOFEN TABLETS USP
52959-677-45	BACLOFEN TABLETS USP
52959-677-60	BACLOFEN TABLETS USP
52959-677-90	BACLOFEN TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-677-02	Baclofen	120 in 1 BOTTLE	TABLET	120	2
52959-677-10	Baclofen	10 in 1 BOTTLE	TABLET	10	2
52959-677-30	Baclofen	30 in 1 BOTTLE	TABLET	30	2
52959-677-45	Baclofen	45 in 1 BOTTLE	TABLET	45	2
52959-677-60	Baclofen	60 in 1 BOTTLE	TABLET	60	2
52959-677-90	Baclofen	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-677-02	EA - Each	52959-677	65794fbf-bf30-47a8-aa7a-176c49620fc7	1	2012-07-24
52959-677-10	EA - Each	52959-677	507bfa99-96e9-4982-9283-2dd742ecff50	1	2012-07-24
52959-677-30	EA - Each	52959-677	4ab8e189-fb11-4f76-883c-b601af14f488	1	2012-07-24
52959-677-45	EA - Each	52959-677	d4a5eb70-d880-4a5a-988c-bd91da528577	1	2012-07-24
52959-677-60	EA - Each	52959-677	3c30bbe4-925d-490f-8b0c-27211f7f57df	1	2012-07-24
52959-677-90	EA - Each	52959-677	acf623c6-4c82-42e2-a059-4ab1567ca0b0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-677	BACLOFEN TABLET [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 6 package rows	20111214_962601f8-7567-4afe-90a0-6df356f5a297.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Proficient Rx LP	9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072235 application number: ANDA072235
Baclofen	BACLOFEN	Teva Pharmaceuticals USA, Inc.	5648c772-50cb-4961-996e-e68a8eb699ea	2019-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072235 application number: ANDA072235

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	962601f8-7567-4afe-90a0-6df356f5a297	2
197392	baclofen 20 MG Oral Tablet	PSN	962601f8-7567-4afe-90a0-6df356f5a297	2
197391	baclofen 10 MG Oral Tablet	SCD	962601f8-7567-4afe-90a0-6df356f5a297	2
197392	baclofen 20 MG Oral Tablet	SCD	962601f8-7567-4afe-90a0-6df356f5a297	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-677-02	52959067702	120 in 1 BOTTLE	Historical
52959-677-10	52959067710	10 in 1 BOTTLE	Historical
52959-677-30	52959067730	30 in 1 BOTTLE	Historical
52959-677-45	52959067745	45 in 1 BOTTLE	Historical
52959-677-60	52959067760	60 in 1 BOTTLE	Historical
52959-677-90	52959067790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS USP	H.J. Harkins Company, Inc. \| IVAX Pharmaceuticals, Inc.	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	2