mexiletine hydrochloride

Generic: mexiletine hydrochloride

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

Drug Facts

Product Profile

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

mexiletine hydrochloride 150 mg/1

Manufacturer
Senores Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 82012-027
Product ID 82012-027_dd924d44-b14d-440c-9670-8faa42422ba1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202111
Listing Expiration 2026-12-31
Marketing Start 2020-03-07

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82012027
Hyphenated Format 82012-027

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
UPC
0382012029041 0382012027047 0382012028044
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 ANDA202111 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (82012-027-04)
source: ndc

Packages (1)

82012-027-04 100 CAPSULE in 1 BOTTLE (82012-027-04)

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": "dd924d44-b14d-440c-9670-8faa42422ba1", "openfda": {"upc": ["0382012029041", "0382012027047", "0382012028044"], "unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["c4a60f9e-fed1-4172-adc4-0be84ac65db9"], "manufacturer_name": ["Senores Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (82012-027-04)", "package_ndc": "82012-027-04", "marketing_start_date": "20211129"}], "brand_name": "MEXILETINE HYDROCHLORIDE", "product_id": "82012-027_dd924d44-b14d-440c-9670-8faa42422ba1", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "82012-027", "generic_name": "mexiletine hydrochloride", "labeler_name": "Senores Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEXILETINE HYDROCHLORIDE", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA202111", "marketing_category": "ANDA", "marketing_start_date": "20200307", "listing_expiration_date": "20261231"}