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 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepack1c6024e9-760b-40a4-9ef1-b75b269c582a2026-08-11Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEAmerisyn LLC58b7a7f5-5ae0-2f60-e063-6394a90a37dd2026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEMacleods Pharmaceuticals Limiteda61a07f6-0b48-4dcd-ad42-5d90f6e69ab12026-05-14Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepackc09f68fa-759e-4772-9f6b-11005d8f83d52026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepack9c2e1055-2fa1-462c-90f3-6d77e89ea38a2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepackb1cb1e35-9586-41c4-b43f-c517f2d42f312026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepack8b192b46-e69f-4031-b843-8b28fa85f07b2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepacka0bd3f2c-44e5-4ad0-9b76-c2028f0cae112026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepacke2c0430d-35ee-460c-b0d5-f117d43430c52026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEAvKAREc528aae3-ff51-b9e4-a401-4ef5910e4b432026-01-15Boxed warning, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEChartwell RX, LLC4e03e02f-c516-479e-9126-86b0df7f8b1c2025-12-17Boxed warning, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEGolden State Medical Supply, Inc.bfe2b847-e18d-cef2-e053-2995a90a42af2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine hydrochlorideMEXILETINE HYDROCHLORIDEAmerican Health Packaging9d0b5d78-63dc-4208-b590-0789d3ed57852025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEANI Pharmaceuticals, Inc.1b3a807f-368a-42dc-8266-ddf8347a88262025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack3aec79aa-9dfb-495f-9280-2b830dc7eae92025-11-06Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack68987377-c7c2-493b-be42-30379ec432bc2025-11-06Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDERising Pharma Holdings, Inc.17c65cba-f56f-4cad-a9e2-d31f62e958492025-02-05Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack0ff45dbf-b555-4f55-a286-98bfaea9ea292024-10-18Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack6cd564bd-24e3-481b-b998-f69f65d67fbe2024-08-08Warnings, Adverse reactionsExact identifier
unii: 606D60IS38
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack2f4239ef-a28a-40d3-9617-2029d492829d2024-05-31Warnings, Adverse reactionsExact identifier
unii: 606D60IS38

Reported adverse events (FAERS/openFDA)#

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