mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 250 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9181
Product ID 63629-9181_e4e4a99f-c012-4701-9df1-dbf824017a41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214089
Listing Expiration 2026-12-31
Marketing Start 2021-11-29

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636299181
Hyphenated Format 63629-9181

Supplemental Identifiers

RxCUI
1362720
UNII
606D60IS38

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 ANDA214089 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (63629-9181-1)
source: ndc

Packages (1)

63629-9181-1 100 CAPSULE in 1 BOTTLE (63629-9181-1)

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": "e4e4a99f-c012-4701-9df1-dbf824017a41", "openfda": {"unii": ["606D60IS38"], "rxcui": ["1362720"], "spl_set_id": ["217fbd7a-1052-42e4-9e84-70519b7b0b7a"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63629-9181-1)", "package_ndc": "63629-9181-1", "marketing_start_date": "20220222"}], "brand_name": "MEXILETINE HYDROCHLORIDE", "product_id": "63629-9181_e4e4a99f-c012-4701-9df1-dbf824017a41", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "63629-9181", "generic_name": "mexiletine hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEXILETINE HYDROCHLORIDE", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA214089", "marketing_category": "ANDA", "marketing_start_date": "20211129", "listing_expiration_date": "20261231"}