Baclofen

Product NDC: 85509-1344
Requested package NDC: 85509-1344-3
11-digit product format: 855091344
Labeler code: 85509
Product ID: 85509-1344_45c6d07c-9d2b-91c2-e063-6394a90aecfd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Baclofen
Dosage form: TABLET
Route: ORAL
Labeler: PHOENIX RX LLC
Application: ANDA212067
Marketing category: ANDA
Marketing start: 2020-07-09
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: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212067-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09
A212067-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09
A212067-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212067-001	AB
A212067-002	AB
A212067-003	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 · 97 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	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212067-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212067-003	BACLOFEN	5MG	TABLET / ORAL	AB	2023-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212067-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-07-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 97 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	A212067-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212067-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212067-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212067-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212067-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212067-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212067-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212067-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212067-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212067-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212067-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212067-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212067-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212067-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212067-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212067-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212067-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212067-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212067-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212067-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212067-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212067-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212067-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212067-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212067-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212067-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212067-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212067-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212067-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212067-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212067-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212067-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212067-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212067-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212067-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212067-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212067-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212067-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212067-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212067-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Baclofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACLOFEN	20 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
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
45c6d45d-95d5-21b8-e063-6294a90a7955	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85509-1344-3	Baclofen	30 in 1 BOTTLE	TABLET	30	1
85509-1344-6	Baclofen	60 in 1 BOTTLE	TABLET	60	1
85509-1344-9	Baclofen	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85509-1344-3	EA - Each	85509-1344	103d82bd-012c-417c-acde-bc1550e58663	1	2026-01-08
85509-1344-6	EA - Each	85509-1344	75378fc4-19a4-4bb0-baf1-d46b8182eb3c	1	2026-01-08
85509-1344-9	EA - Each	85509-1344	80275321-39aa-4aaf-a099-00e5ac5452d7	1	2026-01-08

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	3047613d-006b-4011-b5fe-098588f474aa	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Redpharm Drug	4ce1de84-72e1-57d3-e063-6294a90a220f	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	69d0027a-cb46-4754-9225-071ec1ce4b37	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	REMEDYREPACK INC.	76896b07-2835-4467-b386-87ec66ddd88e	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	PHOENIX RX LLC	45c6d45d-95d5-21b8-e063-6294a90a7955	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067 ndc (package): 85509-1344-3 ndc (product): 85509-1344 ndc11 (package): 85509134403
Baclofen	BACLOFEN	Bryant Ranch Prepack	ab5fd609-3081-4400-90cd-c83b6834d381	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Bryant Ranch Prepack	8cb96e7b-9c40-46a9-b964-7a573b7a0342	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Bryant Ranch Prepack	4b215bc5-f7f9-4b39-b8ee-42b233ee4aa2	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Bryant Ranch Prepack	9bbcbf20-57ed-447b-9744-a5f10b9a057a	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	29987a4c-cf5f-4f98-e063-6394a90a7f19	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Bryant Ranch Prepack	b5fde991-7d12-4083-a3d6-363718f1f6a1	2024-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	19b049cf-56a4-aeaa-e063-6394a90a366d	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067
Baclofen	BACLOFEN	Unichem Pharmaceuticals (USA), Inc.	b9199878-3fb4-46dc-adbb-b3d9dc3852d4	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212067 application number: ANDA212067

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
197392	baclofen 20 MG Oral Tablet	PSN	45c6d45d-95d5-21b8-e063-6294a90a7955	1
197392	baclofen 20 MG Oral Tablet	SCD	45c6d45d-95d5-21b8-e063-6294a90a7955	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85509-1344-3	85509134403	30 TABLET in 1 BOTTLE (85509-1344-3)	30 tablet	2025-12-12	No	No	Current