Baclofen

Product NDC: 63629-3193
Requested package NDC: 63629-3193-3
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	63629-3193-3	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3193	63629-3193-3	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	63629-3193-3	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	63629-3193-3	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	63629-3193-3	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	63629-3193-3	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	63629-3193-3	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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
63629-3193-3	63629319303	60 TABLET in 1 BOTTLE, PLASTIC (63629-3193-3)	60 tablet	2005-08-30	0000-00-00	No	No	Current