Baclofen

Product NDC: 0603-2406
11-digit product format: 006032406
Labeler code: 0603
Product ID: 0603-2406_25fe173e-f3ce-4d70-adec-7e23e455679a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA077068
Marketing category: ANDA
Marketing start: 2005-08-30
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: 2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0603-2406	0603-2406-02	D	Discontinued by firm		2026-08-11
excluded package	package	0603-2406	0603-2406-30	D	Discontinued by firm		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 · 28 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 package	package	0603-2406-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-2406-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-2406-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-2406-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-2406-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-2406-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-2406-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-2406-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-2406-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-2406-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-2406-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-2406-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-2406-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-2406-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-2406-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-2406-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-2406-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-2406-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-2406-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-2406-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-2406-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-2406-02	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-2406-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-2406-02	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0603-2406-21	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0603-2406-28	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0603-2406-32	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077068-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB		2005-08-30
A077068-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		2005-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077068-001	AB
A077068-002	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 3 · 82 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	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077068-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-08-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077068-002	BACLOFEN	10MG	TABLET / ORAL	AB	2005-08-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A077068-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077068-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077068-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077068-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077068-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077068-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077068-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077068-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077068-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077068-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077068-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077068-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077068-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077068-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077068-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077068-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077068-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077068-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077068-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077068-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077068-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077068-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077068-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077068-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077068-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077068-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077068-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077068-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077068-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197391	Internal RxNorm lookup
197392	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
c17527be-661d-42f5-b6f6-56a681ba7870	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0603-2406-02	2022-09-23	BACLOFEN TABLETS, USP
0603-2406-21	2022-09-23	BACLOFEN TABLETS, USP
0603-2406-28	2022-09-23	BACLOFEN TABLETS, USP
0603-2406-30	2022-09-23	BACLOFEN TABLETS, USP
0603-2406-32	2022-09-23	BACLOFEN TABLETS, USP
0603-2406-02	2022-07-29	BACLOFEN TABLETS, USP
0603-2406-21	2022-07-29	BACLOFEN TABLETS, USP
0603-2406-28	2022-07-29	BACLOFEN TABLETS, USP
0603-2406-30	2022-07-29	BACLOFEN TABLETS, USP
0603-2406-32	2022-07-29	BACLOFEN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0603-2406-02	Baclofen	90 in 1 BOTTLE, PLASTIC	TABLET	90	22
0603-2406-21	Baclofen	100 in 1 BOTTLE, PLASTIC	TABLET	100	22
0603-2406-28	Baclofen	500 in 1 BOTTLE, PLASTIC	TABLET	500	22
0603-2406-30	Baclofen	2500 in 1 BOTTLE, PLASTIC	TABLET	2500	22
0603-2406-32	Baclofen	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-2406-02	EA - Each	0603-2406	d414a671-4370-4acf-87e1-fcb1e7b863eb	1	2013-02-13
0603-2406-21	EA - Each	0603-2406	6c4cafb9-f362-4bbe-91c4-5e94f758af8c	1	2012-07-24
0603-2406-28	EA - Each	0603-2406	7faa9177-612f-4334-8818-6ac4f0534f7d	1	2012-07-24
0603-2406-30	EA - Each	0603-2406	d5767d21-b219-4699-bd0a-21b8ec6d8702	1	2013-03-03
0603-2406-32	EA - Each	0603-2406	c2f6bd19-1c65-4f0f-ae9a-5d49cc9f32f3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]	8
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [QUALITEST PHARMACEUTICALS]	8
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [BRYANT RANCH RREPACK]	4
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-2406	BACLOFEN TABLET [ENDO USA, INC.]	21	Current NDC, Legacy NDC, 5 package rows	20250109_c17527be-661d-42f5-b6f6-56a681ba7870.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	Bryant Ranch Prepack	7b6d33d8-58c2-448d-a8df-1de7339b1520	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Bryant Ranch Prepack	4cbb2264-ef65-4906-86e5-349deeeda7a9	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Bryant Ranch Prepack	32525b4e-6384-49e1-a66d-abe45484ab86	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Bryant Ranch Prepack	e13c0563-0f32-4199-acb0-ad2376ec951b	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068
Baclofen	BACLOFEN	Par Health USA, LLC	c17527be-661d-42f5-b6f6-56a681ba7870	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077068 application number: ANDA077068 ndc (product): 0603-2406

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	4cbb2264-ef65-4906-86e5-349deeeda7a9	104
197391	baclofen 10 MG Oral Tablet	SCD	4cbb2264-ef65-4906-86e5-349deeeda7a9	104
197391	baclofen 10 MG Oral Tablet	PSN	7ed13ef7-329e-40cb-b9b1-31a4bf32ac98	100
197391	baclofen 10 MG Oral Tablet	SCD	7ed13ef7-329e-40cb-b9b1-31a4bf32ac98	100
197391	baclofen 10 MG Oral Tablet	PSN	c17527be-661d-42f5-b6f6-56a681ba7870	22
197392	baclofen 20 MG Oral Tablet	PSN	c17527be-661d-42f5-b6f6-56a681ba7870	22
197391	baclofen 10 MG Oral Tablet	SCD	c17527be-661d-42f5-b6f6-56a681ba7870	22
197392	baclofen 20 MG Oral Tablet	SCD	c17527be-661d-42f5-b6f6-56a681ba7870	22
197391	baclofen 10 MG Oral Tablet	PSN	0308ca55-2461-4500-8e35-1d26282d3679	2
197391	baclofen 10 MG Oral Tablet	PSN	0d6c4965-2ea0-4887-9676-76ea3ca93205	2
197392	baclofen 20 MG Oral Tablet	PSN	0308ca55-2461-4500-8e35-1d26282d3679	2
197391	baclofen 10 MG Oral Tablet	SCD	0d6c4965-2ea0-4887-9676-76ea3ca93205	2
197391	baclofen 10 MG Oral Tablet	SCD	0308ca55-2461-4500-8e35-1d26282d3679	2
197392	baclofen 20 MG Oral Tablet	SCD	0308ca55-2461-4500-8e35-1d26282d3679	2
197391	baclofen 10 MG Oral Tablet	PSN	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1
197391	baclofen 10 MG Oral Tablet	PSN	b127bc0c-6e3b-4906-ab5f-6992a9775038	1
197391	baclofen 10 MG Oral Tablet	PSN	dd4b9972-0295-4555-a90b-bb087170cfbb	1
197392	baclofen 20 MG Oral Tablet	PSN	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1
197392	baclofen 20 MG Oral Tablet	PSN	b127bc0c-6e3b-4906-ab5f-6992a9775038	1
197391	baclofen 10 MG Oral Tablet	SCD	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1
197391	baclofen 10 MG Oral Tablet	SCD	b127bc0c-6e3b-4906-ab5f-6992a9775038	1
197391	baclofen 10 MG Oral Tablet	SCD	dd4b9972-0295-4555-a90b-bb087170cfbb	1
197392	baclofen 20 MG Oral Tablet	SCD	2a7e8eb1-6a38-47b1-bc2b-b59f709f8cda	1
197392	baclofen 20 MG Oral Tablet	SCD	b127bc0c-6e3b-4906-ab5f-6992a9775038	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-2406-02	00603240602	90 in 1 BOTTLE, PLASTIC						Historical
0603-2406-21	00603240621	100 TABLET in 1 BOTTLE, PLASTIC (0603-2406-21)	100 tablet	2005-08-30	0000-00-00	No	No	Current
0603-2406-28	00603240628	500 TABLET in 1 BOTTLE, PLASTIC (0603-2406-28)	500 tablet	2005-08-30	0000-00-00	No	No	Current
0603-2406-30	00603240630	2500 in 1 BOTTLE, PLASTIC						Historical
0603-2406-32	00603240632	1000 TABLET in 1 BOTTLE, PLASTIC (0603-2406-32)	1000 tablet	2005-08-30	2027-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BACLOFEN TABLETS, USP	Bryant Ranch Prepack	2024-12-05	HUMAN PRESCRIPTION DRUG LABEL	104
BACLOFEN TABLETS, USP	Par Health USA, LLC	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	22
Baclofen Tablets, USP	REMEDYREPACK INC.	2024-08-16	HUMAN PRESCRIPTION DRUG LABEL	12
Baclofen Tablets, USP	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
BACLOFEN TABLETS, USP	Bryant Ranch Prepack	2023-08-29	HUMAN PRESCRIPTION DRUG LABEL	100
Baclofen Tablets, USP	A-S Medication Solutions	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	6
Baclofen Tablets, USP	Bryant Ranch Prepack	2019-08-17	HUMAN PRESCRIPTION DRUG LABEL	11
Baclofen Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2017-12-07	HUMAN PRESCRIPTION DRUG LABEL	1
BACLOFEN TABLETS, USP	Blenheim Pharmacal, Inc.	2015-04-09	HUMAN PRESCRIPTION DRUG LABEL	2
BACLOFEN TABLETS, USP	State of Florida DOH Central Pharmacy	2014-10-08	HUMAN PRESCRIPTION DRUG LABEL	2
BACLOFEN TABLETS, USP	Aidarex Pharmaceuticals LLC	2013-12-12	HUMAN PRESCRIPTION DRUG LABEL	1
BACLOFEN TABLETS, USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-08-02	HUMAN PRESCRIPTION DRUG LABEL	1