BACLOFEN

Product NDC: 67296-2259
11-digit product format: 672962259
Labeler code: 67296
Product ID: 67296-2259_53df2f3a-7ad9-be91-e063-6394a90a680d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA209102
Marketing category: ANDA
Marketing start: 2018-04-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209102-001	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2017-11-28
A209102-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2017-11-28
A209102-003	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2017-11-28
A209102-004	BACLOFEN	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A209102-001	AB
A209102-002	AB
A209102-003	AB
A209102-004	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 4 · 148 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
2026-09-14 22:38:34	2026-08	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB		2017-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB		2017-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	RS	2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB		2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB		2017-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB		2024-02-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 143 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209102-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209102-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209102-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209102-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209102-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209102-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209102-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209102-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209102-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209102-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209102-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209102-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209102-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209102-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197391	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
53df4b4b-842e-9e3a-e063-6394a90a8a3d	Available on FDA.report

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	9834e409-8633-4f99-8ac7-7fa298d01c44	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	adc072b9-e48b-470d-9eb1-fd7b52c1f122	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	TruPharma LLC	68aa591e-ea98-4438-9a4a-4f7e9ea2b285	2024-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	NCS HealthCare of KY, LLC dba Vangard Labs	2927228a-7a3e-4e1d-ab5f-4407b00f6899	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102

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	Sample	Exclude flag	Status
67296-2259-3	67296225903	30 TABLET in 1 BOTTLE (67296-2259-3)	30 tablet	2018-04-01	No	No	Current