mexiletine hydrochloride

Generic: mexiletine hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mexiletine hydrochloride
Generic Name mexiletine hydrochloride
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mexiletine hydrochloride 250 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-626
Product ID 42291-626_4870f872-0804-7f08-e063-6394a90a19e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074377
Listing Expiration 2027-12-31
Marketing Start 2013-07-09

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291626
Hyphenated Format 42291-626

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
UPC
0342291625013
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 ANDA074377 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42291-626-01)
source: ndc

Packages (1)

42291-626-01 100 CAPSULE in 1 BOTTLE (42291-626-01)

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": "4870f872-0804-7f08-e063-6394a90a19e9", "openfda": {"upc": ["0342291625013"], "unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["c528aae3-ff51-b9e4-a401-4ef5910e4b43"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42291-626-01)", "package_ndc": "42291-626-01", "marketing_start_date": "20130709"}], "brand_name": "Mexiletine Hydrochloride", "product_id": "42291-626_4870f872-0804-7f08-e063-6394a90a19e9", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "42291-626", "generic_name": "Mexiletine Hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mexiletine Hydrochloride", "active_ingredients": [{"name": "MEXILETINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA074377", "marketing_category": "ANDA", "marketing_start_date": "20130709", "listing_expiration_date": "20271231"}