BACLOFEN

Product NDC: 85534-0004
11-digit product format: 855340004
Labeler code: 85534
Product ID: 85534-0004_37457bd5-2fd0-b829-e063-6294a90a04f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA214099
Marketing category: ANDA
Marketing start: 2021-07-13
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 43.

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
A214099-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13
A214099-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13
A214099-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2025-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214099-001	AB
A214099-002	AB
A214099-003	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 2 · 75 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
2026-09-14 22:38:34	2026-08	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214099-003	BACLOFEN	5MG	TABLET / ORAL	AB	2025-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214099-003	BACLOFEN	5MG	TABLET / ORAL	AB	2025-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214099-003	BACLOFEN	5MG	TABLET / ORAL	AB	2025-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214099-003	BACLOFEN	5MG	TABLET / ORAL	AB	2025-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 75 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	A214099-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214099-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214099-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214099-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214099-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214099-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214099-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214099-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214099-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214099-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214099-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214099-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214099-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214099-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214099-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214099-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214099-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214099-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214099-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214099-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214099-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214099-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214099-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214099-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214099-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214099-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214099-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214099-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214099-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214099-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214099-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214099-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214099-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214099-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214099-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214099-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214099-002	AB	1	`5d02ea3f76ae…`

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: 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
bc48a775-1feb-44c4-9453-e1ccf3d929bd	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
85534-0004-0	BACLOFEN	100 in 1 BOTTLE	TABLET	100	1
85534-0004-1	BACLOFEN	120 in 1 BOTTLE	TABLET	120	1
85534-0004-3	BACLOFEN	30 in 1 BOTTLE	TABLET	30	1
85534-0004-6	BACLOFEN	60 in 1 BOTTLE	TABLET	60	1
85534-0004-9	BACLOFEN	90 in 1 BOTTLE	TABLET	90	1

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	REMEDYREPACK INC.	355266e4-68f7-47d7-9f4e-1a0fc912786d	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Medcore LLC	13eca70c-3cc8-4317-83cf-ade3327e48c0	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	9bd46eb6-53b2-4845-88b4-81c1ced08aaa	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	3fdfeef9-68b3-4f6c-a4de-28179758a962	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Aurobindo Pharma Limited	f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	844a09ab-6c11-44fa-a09b-09e2b7a3759e	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	HAWAII REPACK, INC.	bc48a775-1feb-44c4-9453-e1ccf3d929bd	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099 ndc (product): 85534-0004
BACLOFEN	BACLOFEN	Aurobindo Pharma Limited	4679a275-9307-4b0f-a2eb-2d83227ea84d	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	NuCare Pharmaceuticals,Inc.	fd00fa8f-2797-c3f0-e053-6294a90a975f	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	687f48da-bc41-4700-9513-77a32fc86c93	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a58145a-57f9-6bb1-e063-6294a90a32a8	2024-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a586399-49e9-1e5c-e063-6294a90a4872	2024-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099
BACLOFEN	BACLOFEN	Quality Care Products, LLC	67df80a6-7fff-496e-9a89-d43a06c2a11f	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214099 application number: ANDA214099

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	bc48a775-1feb-44c4-9453-e1ccf3d929bd	1
197392	baclofen 20 MG Oral Tablet	SCD	bc48a775-1feb-44c4-9453-e1ccf3d929bd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85534-0004-0	85534000400	100 TABLET in 1 BOTTLE (85534-0004-0)	100 tablet	2025-06-11	No	No	Current
85534-0004-1	85534000401	120 TABLET in 1 BOTTLE (85534-0004-1)	120 tablet	2025-06-11	No	No	Current
85534-0004-3	85534000403	30 TABLET in 1 BOTTLE (85534-0004-3)	30 tablet	2025-06-11	No	No	Current
85534-0004-6	85534000406	60 TABLET in 1 BOTTLE (85534-0004-6)	60 tablet	2025-06-11	No	No	Current
85534-0004-9	85534000409	90 TABLET in 1 BOTTLE (85534-0004-9)	90 tablet	2025-06-11	No	No	Current