mexiletine hydrochloride

Generic: mexiletine hydrochloride

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

Drug Facts

Product Profile

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

mexiletine hydrochloride 200 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-821
Product ID 62559-821_2c6414d2-b1f3-4645-ae4f-5e5be0558e3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074450
Listing Expiration 2026-12-31
Marketing Start 2020-06-22

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62559821
Hyphenated Format 62559-821

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
UPC
0362559820011 0362559821018 0362559822015
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 ANDA074450 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (62559-821-01)
source: ndc

Packages (1)

62559-821-01 100 CAPSULE in 1 BOTTLE (62559-821-01)

Ingredients (1)

mexiletine hydrochloride (200 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": "2c6414d2-b1f3-4645-ae4f-5e5be0558e3f", "openfda": {"upc": ["0362559820011", "0362559821018", "0362559822015"], "unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["1b3a807f-368a-42dc-8266-ddf8347a8826"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62559-821-01)", "package_ndc": "62559-821-01", "marketing_start_date": "20200622"}], "brand_name": "Mexiletine Hydrochloride", "product_id": "62559-821_2c6414d2-b1f3-4645-ae4f-5e5be0558e3f", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "62559-821", "generic_name": "Mexiletine Hydrochloride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mexiletine Hydrochloride", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA074450", "marketing_category": "ANDA", "marketing_start_date": "20200622", "listing_expiration_date": "20261231"}