Baclofen

Product NDC: 63629-3193
Requested package NDC: 63629-3193-8
11-digit product format: 636293193
Labeler code: 63629
Product ID: 63629-3193_bf500d4b-4dd6-4710-85fa-b62096912c24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077068
Marketing category: ANDA
Marketing start: 2005-08-30
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: No
Listing certified through: 2020-12-31
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	63629-3193	63629-3193-8	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3193	63629-3193-8	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3193-0	EA - Each	63629-3193	23b04d58-82a8-4b1e-a444-e036b47660fd	1	2019-05-02
63629-3193-1	EA - Each	63629-3193	d3dbec37-a51f-4748-83cc-22fe50e0e5a9	1	2012-07-24
63629-3193-2	EA - Each	63629-3193	66f79331-a15f-4082-b40d-76e47372d5d6	1	2012-07-24
63629-3193-3	EA - Each	63629-3193	c0699e0b-255f-49b5-891e-06c4e33ed327	1	2012-07-24
63629-3193-4	EA - Each	63629-3193	33f03c2e-c57c-4fc7-95d2-ed3d0ff70ffb	1	2012-07-24
63629-3193-5	EA - Each	63629-3193	cb728474-3b0d-4735-a1b2-4ec7ecb88af2	1	2012-07-24
63629-3193-6	EA - Each	63629-3193	58fb7f40-b612-4e56-a8ba-c1e8badd8a09	1	2012-07-24
63629-3193-7	EA - Each	63629-3193	3ac61397-b534-4344-b63b-bf87c0f95a36	1	2012-07-24
63629-3193-8	EA - Each	63629-3193	0b3747c5-5239-4eeb-a737-0185f34c1525	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H789N3FKE8	BACLOFEN	1134-47-0	BACLOFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3193-8	63629319308	15 TABLET in 1 BOTTLE, PLASTIC (63629-3193-8)	15 tablet	2005-08-30	0000-00-00	No	No	Current