NDC 0591-0492-01 - Mexiletine HCl

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: 0591-0492
Requested NDC: 0591-0492-01
Package NDCs from labels: 0591-0492-01, 0591-0492-05
Manufacturer: Watson Laboratories, Inc.
Effective date: 2008-04-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Mexiletine Hydrochloride Capsules USP Rx only	Watson Laboratories, Inc.	2008-04-29	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-0492-01	Mexiletine HCl	100 in 1 BOTTLE	CAPSULE	100		2
0591-0492-05	Mexiletine HCl	500 in 1 BOTTLE	CAPSULE	500		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-0492	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2	2 package rows	20080521_AB73778B-6794-441C-B127-610A6D0733EA.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mexiletine hydrochloride	ACTIVE INGREDIENT	606D60IS38	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
Mexiletine	ACTIVE MOIETY	1U511HHV4Z	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
black iron oxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
colloidal silicon dioxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
corn starch	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
D & C Red No. 28	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
D & C Yellow No. 10	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
FD & C Blue No. 1	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
FD & C Green No. 3	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
FD & C Red No. 40	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
pregelatinized starch	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
red iron oxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
yellow iron oxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	9099b620-eae9-48f9-9d5f-8fd22c32b2b0	2024-04-04	Warnings, Adverse reactions	Exact identifier rxcui: 1362706
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	41930321-15e3-4ddf-ba5d-3655ce5f2923	2023-10-24	Warnings, Adverse reactions	Exact identifier rxcui: 1362712
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	217fbd7a-1052-42e4-9e84-70519b7b0b7a	2023-10-24	Warnings, Adverse reactions	Exact identifier rxcui: 1362720
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	6dbf86f7-2b2d-40fb-868b-ee7d7a95556e	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Senores Pharmaceuticals, Inc.	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	2d0c61ca-4c99-42f9-8f00-e0e9d2672a39	2023-04-27	Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
Mexiletine hydrochloride	MEXILETINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	8b20e850-037b-4c16-a57d-c3d4909f147a	2022-11-16	Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	693da40b-26d4-40d6-87d1-158e256f40ab	2022-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
613F0349-1D4C-9F2D-3A6C-FD6024230418			AB73778B-6794-441C-B127-610A6D0733EA	2008-04-29	Adverse reactions	Exact identifier spl id: 613F0349-1D4C-9F2D-3A6C-FD6024230418 spl set id: AB73778B-6794-441C-B127-610A6D0733EA

Reported adverse events (FAERS/openFDA)#

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