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 9 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Chartwell RX, LLC	2a75db96-590a-43cf-aefb-3bbcb287dbf0	2024-10-10	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	NCS HealthCare of KY, LLC dba Vangard Labs	ea4ad5c5-207c-4a68-8e6e-4ff101777e5c	2024-10-04	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
Baclofen	BACLOFEN	Proficient Rx LP	b981eb16-a195-41da-a186-3e91b63b2def	2024-10-01	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Proficient Rx LP	9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc	2024-10-01	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	f9c6d75a-a956-47b6-a5a2-deaf9797e2b2	2024-09-16	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	08a6866f-b127-482f-9f22-113175487bdd	2024-09-12	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	5b92b0a6-ebba-4815-8b94-f2014674399b	2024-09-05	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	4634093b-6def-41d6-a7f3-23040125c4f4	2024-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	655db2a3-daf7-4f4b-8f64-4a6d81fdc165	2024-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	b5fde991-7d12-4083-a3d6-363718f1f6a1	2024-08-16	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Zydus Lifesciences Limited	bb5c6faa-2933-44d1-8706-8302150be734	2024-08-12	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Zydus Pharmaceuticals (USA) Inc.	cfc49176-8d01-4c39-9319-604dd087065c	2024-08-12	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	NuCare Pharmaceuticals,Inc.	b2be2e6c-a247-30f4-e053-2a95a90a6ccb	2024-07-17	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Direct_rx	1bf59c3b-f8eb-972e-e063-6394a90aeccc	2024-06-28	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	NuCare Pharmaceuticals,Inc.	9c1c4911-908e-3c3c-e053-2995a90abcfc	2024-06-14	Warnings	Exact identifier unii: FZ989GH94E
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	9834e409-8633-4f99-8ac7-7fa298d01c44	2024-05-30	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	19b049cf-56a4-aeaa-e063-6394a90a366d	2024-05-30	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	adc072b9-e48b-470d-9eb1-fd7b52c1f122	2024-05-29	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	TruPharma LLC	68aa591e-ea98-4438-9a4a-4f7e9ea2b285	2024-04-17	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	d24135b3-e247-412f-a10b-ceecbdee3aef	2024-04-02	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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