NDC 0591-5731 - Baclofen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0591-5731
Package NDCs from labels: 0591-5731-01, 0591-5731-05
Manufacturer: Med Health Pharma, LLC
Effective date: 2011-01-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Baclofen - Med Health Pharma, LLC	Med Health Pharma, LLC	2011-01-01	HUMAN PRESCRIPTION DRUG LABEL
BACLOFEN - STAT RX USA LLC	STAT RX USA LLC	2010-06-29	HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP 10mg & 20mg	Rebel Distributors Corp.	2009-12-01	HUMAN PRESCRIPTION DRUG LABEL
Baclofen Tablets USP Revised: January 2004 Rx only	Watson Laboratories, Inc.	2007-01-08	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-5731-01	Bacolfen	100 in 1 BOTTLE	TABLET	100		3
0591-5731-05	Bacolfen	500 in 1 BOTTLE	TABLET	500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5731	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3	2 package rows	20070126_AADEE2AB-113B-4CD4-8184-575C3F496990.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
baclofen	ACTIVE MOIETY	H789N3FKE8	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Corn starch	INACTIVE INGREDIENT		BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Microcrystalline cellulose	INACTIVE INGREDIENT		BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Povidone	INACTIVE INGREDIENT		BACOLFEN (BACOLFEN) TABLET [WATSON LABORATORIES, INC.]	3
Baclofen	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [MED HEALTH PHARMA, LLC]	2
Baclofen	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [MED HEALTH PHARMA, LLC]	2
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [STAT RX USA LLC]	1
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [STAT RX USA LLC]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [STAT RX USA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	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 8 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Bryant Ranch Prepack	9bbcbf20-57ed-447b-9744-a5f10b9a057a	2025-01-22	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	687f48da-bc41-4700-9513-77a32fc86c93	2025-01-15	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Nexus Pharmaceuticals LLC	68c9ade0-d783-43e9-8a3f-a16ec1501ec1	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c534d-4fa3-0a2f-e053-2995a90ab52f	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c4164-e607-2e27-e053-2a95a90ad7db	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	b4f2f888-979a-6f54-e053-2a95a90a95a3	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	c85a1884-f46f-5cd4-e053-2a95a90a3e27	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	c85a9d82-1d61-aeec-e053-2995a90a03a4	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	ec09736a-dd2b-0a3b-e053-2995a90a9542	2024-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a58145a-57f9-6bb1-e063-6294a90a32a8	2024-12-29	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a586399-49e9-1e5c-e063-6294a90a4872	2024-12-28	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	29987a4c-cf5f-4f98-e063-6394a90a7f19	2024-12-19	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Quality Care Products, LLC	67df80a6-7fff-496e-9a89-d43a06c2a11f	2024-12-19	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	7b6d33d8-58c2-448d-a8df-1de7339b1520	2024-12-12	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	4cbb2264-ef65-4906-86e5-349deeeda7a9	2024-12-05	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	32525b4e-6384-49e1-a66d-abe45484ab86	2024-12-05	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	e13c0563-0f32-4199-acb0-ad2376ec951b	2024-12-05	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	43cafbdb-6927-45f6-9b16-3b125cc2a29d	2024-11-27	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	f5edb656-4f7e-2386-e053-2995a90a70de	2024-11-15	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Clear Eyes Triple Relief	POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	1269a1a6-843d-4d08-bb3c-c1f3d2e7080d	2024-10-25	Warnings	Exact identifier unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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