mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler ingenus pharmaceuticals, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 200 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-240
Product ID 50742-240_64851116-6653-4b86-9bc0-24f93b4ece10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214352
Listing Expiration 2026-12-31
Marketing Start 2021-01-26

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742240
Hyphenated Format 50742-240

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
UPC
0350742239016 0350742240012 0350742241019
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 ANDA214352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (50742-240-01)
source: ndc

Packages (1)

50742-240-01 100 CAPSULE in 1 BOTTLE (50742-240-01)

Ingredients (1)

mexiletine hydrochloride (200 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": "64851116-6653-4b86-9bc0-24f93b4ece10", "openfda": {"upc": ["0350742239016", "0350742240012", "0350742241019"], "unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["6dbf86f7-2b2d-40fb-868b-ee7d7a95556e"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (50742-240-01)", "package_ndc": "50742-240-01", "marketing_start_date": "20210126"}], "brand_name": "MEXILETINE HYDROCHLORIDE", "product_id": "50742-240_64851116-6653-4b86-9bc0-24f93b4ece10", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "50742-240", "generic_name": "Mexiletine hydrochloride", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEXILETINE HYDROCHLORIDE", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA214352", "marketing_category": "ANDA", "marketing_start_date": "20210126", "listing_expiration_date": "20261231"}