mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 150 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-666
Product ID 64980-666_17c65cba-f56f-4cad-a9e2-d31f62e95849
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215315
Listing Expiration 2026-12-31
Marketing Start 2025-02-05

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980666
Hyphenated Format 64980-666

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
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 ANDA215315 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (64980-666-01)
source: ndc

Packages (1)

64980-666-01 100 CAPSULE in 1 BOTTLE (64980-666-01)

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": "17c65cba-f56f-4cad-a9e2-d31f62e95849", "openfda": {"unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["17c65cba-f56f-4cad-a9e2-d31f62e95849"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64980-666-01)", "package_ndc": "64980-666-01", "marketing_start_date": "20250205"}], "brand_name": "Mexiletine Hydrochloride", "product_id": "64980-666_17c65cba-f56f-4cad-a9e2-d31f62e95849", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "64980-666", "generic_name": "Mexiletine Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mexiletine Hydrochloride", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA215315", "marketing_category": "ANDA", "marketing_start_date": "20250205", "listing_expiration_date": "20261231"}