BACLOFEN

Product NDC: 70518-3614
11-digit product format: 705183614
Labeler code: 70518
Product ID: 70518-3614_4f6b3ea4-9fcf-af92-e063-6394a90abb28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BACLOFEN
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA209102
Marketing category: ANDA
Marketing start: 2023-01-09
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

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	70518-3614	70518-3614-0	D	Discontinued by firm		2026-07-31

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

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.

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	A209102-001	BACLOFEN	5MG	TABLET / ORAL	AB	2017-11-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209102-002	BACLOFEN	10MG	TABLET / ORAL	AB	2017-11-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209102-003	BACLOFEN	20MG	TABLET / ORAL	AB	2017-11-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209102-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-05	`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	A209102-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209102-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209102-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A209102-004	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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Redpharm Drug	53df4b4b-842e-9e3a-e063-6394a90a8a3d	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	e017a001-8cb1-4dd8-960e-c6d74005f57f	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ac9b720f-b755-49f1-9850-efb26feadaeb	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102 ndc (product): 70518-3614
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	ee59a379-17d5-487f-b72f-a53e74744a70	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	91175128-8285-4d04-89a9-219781be9260	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	16266972-843e-4ea5-be1f-fb1b1588a5dc	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	0a1d09ac-94d5-45ef-92cc-bc261c2b2d75	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Major Pharmaceuticals	46f84504-ffc4-4be5-9598-c20a3f4210f4	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Advagen Pharma Limited	04dac0f6-cc6c-4959-9bca-a6e4a99690f3	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	00c6c924-ddfd-4a75-afd7-f6561ff9abbc	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	459ec5f5-4f99-e917-e063-6294a90a23cd	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	SOLA Pharmaceuticals, LLC	7b308b35-8c08-458d-860e-c78d057e8260	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Proficient Rx LP	0680301a-1649-46c4-b74e-ab03967945d0	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	5cba5255-e5ad-48fd-8385-60e9ea6b6407	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	4e2cd27d-91c7-4f15-96cc-3971769dbeaa	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	35bccefe-8d2e-85b5-e063-6394a90a58ca	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	A-S Medication Solutions	eb690a49-b87b-433f-9afe-2966406fe00e	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	A-S Medication Solutions	af0ade6c-9dd4-42d3-879e-4201fbe585ee	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
BACLOFEN	BACLOFEN	Proficient Rx LP	0243dd97-1d40-48f7-8853-76e046c605f2	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102
Baclofen	BACLOFEN	Direct_Rx	020632f4-5e8a-f4a0-e063-6294a90a6301	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209102 application number: ANDA209102

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
ac9b720f-b755-49f1-9850-efb26feadaeb	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
70518-3614-0	BACLOFEN	30 in 1 BLISTER PACK	TABLET	30	8
70518-3614-1	BACLOFEN	90 in 1 BOTTLE, PLASTIC	TABLET	90	8
70518-3614-2	BACLOFEN	30 in 1 BOTTLE, PLASTIC	TABLET	30	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-3614-1	EA - Each	70518-3614	bfda1458-fcf3-48cd-b519-e0c357f63b0b	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3614	BACLOFEN TABLET [REMEDYREPACK INC.]	5	Current NDC, Legacy NDC, 3 package rows	20241122_ac9b720f-b755-49f1-9850-efb26feadaeb.zip

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
197391	baclofen 10 MG Oral Tablet	PSN	ac9b720f-b755-49f1-9850-efb26feadaeb	8
197391	baclofen 10 MG Oral Tablet	SCD	ac9b720f-b755-49f1-9850-efb26feadaeb	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3614-0	70518361400	30 TABLET in 1 BLISTER PACK (70518-3614-0)	30 tablet	2023-01-09	0000-00-00	No	No	Current
70518-3614-1	70518361401	90 TABLET in 1 BOTTLE, PLASTIC (70518-3614-1)	90 tablet	2023-08-31		No	No	Current
70518-3614-2	70518361402	30 TABLET in 1 BOTTLE, PLASTIC (70518-3614-2)	30 tablet	2023-09-27		No	No	Current