mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler lannett company, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 150 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-4107
Product ID 0527-4107_8da7d3ff-0e0c-4401-8ced-81bbc16c230b
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 05274107
Hyphenated Format 0527-4107

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
UPC
0305274107371 0305274109375 0305274108378
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
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0527-4107-37)
source: ndc

Packages (1)

0527-4107-37 100 CAPSULE in 1 BOTTLE (0527-4107-37)

Ingredients (1)

mexiletine hydrochloride (150 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": "8da7d3ff-0e0c-4401-8ced-81bbc16c230b", "openfda": {"upc": ["0305274107371", "0305274109375", "0305274108378"], "unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["4cf19b14-050e-4083-8f1e-6618310e02f1"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0527-4107-37)", "package_ndc": "0527-4107-37", "marketing_start_date": "20200723"}], "brand_name": "Mexiletine Hydrochloride", "product_id": "0527-4107_8da7d3ff-0e0c-4401-8ced-81bbc16c230b", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "0527-4107", "generic_name": "Mexiletine Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mexiletine Hydrochloride", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA213500", "marketing_category": "ANDA", "marketing_start_date": "20200723", "listing_expiration_date": "20261231"}