mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 250 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8741
Product ID 0093-8741_e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074377
Listing Expiration 2026-12-31
Marketing Start 1995-06-05

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00938741
Hyphenated Format 0093-8741

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
UPC
0300938741014 0300938739011
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 ANDA074377 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0093-8741-01)
source: ndc

Packages (1)

0093-8741-01 100 CAPSULE in 1 BOTTLE (0093-8741-01)

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": "e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9", "openfda": {"upc": ["0300938741014", "0300938739011"], "unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["693da40b-26d4-40d6-87d1-158e256f40ab"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0093-8741-01)", "package_ndc": "0093-8741-01", "marketing_start_date": "19950605"}], "brand_name": "Mexiletine Hydrochloride", "product_id": "0093-8741_e7a9997c-4cf7-4cf1-94c0-ff60f15ae0f9", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "0093-8741", "generic_name": "Mexiletine Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mexiletine Hydrochloride", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA074377", "marketing_category": "ANDA", "marketing_start_date": "19950605", "listing_expiration_date": "20261231"}