NDC 73309-062-01 - Mexiletine Hydrochloride

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: 73309-062
Requested NDC: 73309-062-01
Package NDCs from labels: 73309-062-01
Manufacturer: BLUEBAY SHANDONG CO.,LTD
Effective date: 2019-11-29
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 - BLUEBAY SHANDONG CO.,LTD	BLUEBAY SHANDONG CO.,LTD	2019-11-29	BULK INGREDIENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73309-062-01	Mexiletine Hydrochloride	1 kg in 1 JAR	POWDER	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73309-062	MEXILETINE HYDROCHLORIDE POWDER [BLUEBAY SHANDONG CO.,LTD]	1	1 package rows	20191130_d3ff8d98-80c3-4458-8de7-01955ccd1ac9.zip

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 · 28 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 unii: 606D60IS38
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	41930321-15e3-4ddf-ba5d-3655ce5f2923	2023-10-24	Warnings, Adverse reactions	Exact identifier unii: 606D60IS38
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	217fbd7a-1052-42e4-9e84-70519b7b0b7a	2023-10-24	Warnings, Adverse reactions	Exact identifier unii: 606D60IS38
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Ingenus Pharmaceuticals, LLC	6dbf86f7-2b2d-40fb-868b-ee7d7a95556e	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 606D60IS38
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Senores Pharmaceuticals, Inc.	c4a60f9e-fed1-4172-adc4-0be84ac65db9	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 606D60IS38
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	2d0c61ca-4c99-42f9-8f00-e0e9d2672a39	2023-04-27	Warnings, Adverse reactions	Exact identifier unii: 606D60IS38
Mexiletine hydrochloride	MEXILETINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	8b20e850-037b-4c16-a57d-c3d4909f147a	2022-11-16	Warnings, Adverse reactions	Exact identifier unii: 606D60IS38
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	693da40b-26d4-40d6-87d1-158e256f40ab	2022-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 606D60IS38

Reported adverse events (FAERS/openFDA)#

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