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 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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A214099-001	BACLOFEN	10MG	TABLET / ORAL	AB	2021-07-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214099-002	BACLOFEN	20MG	TABLET / ORAL	AB	2021-07-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214099-003	BACLOFEN	5MG	TABLET / ORAL	AB	2025-11-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A214099-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214099-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214099-003	AB	1	`a50c72e98297…`

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 · 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	2026-04-10	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

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

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