mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler american health packaging
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 150 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-778
Product ID 60687-778_43551356-5d60-0b13-e063-6394a90a6cd7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216463
Listing Expiration 2026-12-31
Marketing Start 2024-02-23

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687778
Hyphenated Format 60687-778

Supplemental Identifiers

RxCUI
1362706
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 ANDA216463 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60687-778-21) / 1 CAPSULE in 1 BLISTER PACK (60687-778-11)
source: ndc

Packages (1)

60687-778-21 30 BLISTER PACK in 1 CARTON (60687-778-21) / 1 CAPSULE in 1 BLISTER PACK (60687-778-11)

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": "43551356-5d60-0b13-e063-6394a90a6cd7", "openfda": {"unii": ["606D60IS38"], "rxcui": ["1362706"], "spl_set_id": ["9d0b5d78-63dc-4208-b590-0789d3ed5785"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60687-778-21)  / 1 CAPSULE in 1 BLISTER PACK (60687-778-11)", "package_ndc": "60687-778-21", "marketing_start_date": "20240223"}], "brand_name": "Mexiletine hydrochloride", "product_id": "60687-778_43551356-5d60-0b13-e063-6394a90a6cd7", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "60687-778", "generic_name": "Mexiletine hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mexiletine hydrochloride", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA216463", "marketing_category": "ANDA", "marketing_start_date": "20240223", "listing_expiration_date": "20261231"}