FDA.reportPublic FDA data

NDC 73377-323 - 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
73377-323
Package NDCs from labels
73377-323-01
Manufacturer
AX Pharmaceutical Corp
Effective date
2025-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mexiletine HCl - AX Pharmaceutical CorpAX Pharmaceutical Corp2025-05-12BULK INGREDIENT - ANIMAL DRUG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73377-323-01Mexiletine HCl500 g in 1 JARPOWDER5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-323MEXILETINE HCL POWDER [AX PHARMACEUTICAL CORP]11 package rows20250514_b635fe28-11a7-4ea4-85d5-54d8b3aa896f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack9099b620-eae9-48f9-9d5f-8fd22c32b2b02024-04-04Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack41930321-15e3-4ddf-ba5d-3655ce5f29232023-10-24Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack217fbd7a-1052-42e4-9e84-70519b7b0b7a2023-10-24Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC6dbf86f7-2b2d-40fb-868b-ee7d7a95556e2023-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDESenores Pharmaceuticals, Inc.c4a60f9e-fed1-4172-adc4-0be84ac65db92023-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.2d0c61ca-4c99-42f9-8f00-e0e9d2672a392023-04-27Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine hydrochlorideMEXILETINE HYDROCHLORIDECamber Pharmaceuticals, Inc.8b20e850-037b-4c16-a57d-c3d4909f147a2022-11-16Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.693da40b-26d4-40d6-87d1-158e256f40ab2022-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38

Reported adverse events (FAERS/openFDA)#

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