mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler chartwell rx, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 250 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-785
Product ID 62135-785_462a5c01-c4ca-6bfa-e063-6294a90a4dd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213500
Listing Expiration 2026-12-31
Marketing Start 2020-07-23

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135785
Hyphenated Format 62135-785

Supplemental Identifiers

RxCUI
1362720
UPC
0362135785901
UNII
606D60IS38

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mexiletine hydrochloride (source: ndc)
Generic Name mexiletine hydrochloride (source: ndc)
Application Number ANDA213500 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (62135-785-90)
source: ndc

Packages (1)

62135-785-90 90 CAPSULE in 1 BOTTLE (62135-785-90)

Ingredients (1)

mexiletine hydrochloride (250 mg/1)

Linked Drug Pages (1)

MEXILETINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "462a5c01-c4ca-6bfa-e063-6294a90a4dd9", "openfda": {"upc": ["0362135785901"], "unii": ["606D60IS38"], "rxcui": ["1362720"], "spl_set_id": ["4e03e02f-c516-479e-9126-86b0df7f8b1c"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (62135-785-90)", "package_ndc": "62135-785-90", "marketing_start_date": "20231025"}], "brand_name": "MEXILETINE HYDROCHLORIDE", "product_id": "62135-785_462a5c01-c4ca-6bfa-e063-6294a90a4dd9", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "62135-785", "generic_name": "mexiletine hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEXILETINE HYDROCHLORIDE", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA213500", "marketing_category": "ANDA", "marketing_start_date": "20200723", "listing_expiration_date": "20261231"}