mexiletine hydrochloride

Generic: mexiletine hydrochloride

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

Drug Facts

Product Profile

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

mexiletine hydrochloride 150 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-036
Product ID 31722-036_ed93311a-2bfc-3875-e053-2a95a90ac6f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216463
Listing Expiration 2026-12-31
Marketing Start 2022-11-09

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722036
Hyphenated Format 31722-036

Supplemental Identifiers

RxCUI
1362706 1362712 1362720
UPC
0331722036016 0331722037013 0331722038010
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 ANDA216463 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (31722-036-01)
source: ndc

Packages (1)

31722-036-01 100 CAPSULE in 1 BOTTLE (31722-036-01)

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": "ed93311a-2bfc-3875-e053-2a95a90ac6f0", "openfda": {"upc": ["0331722036016", "0331722037013", "0331722038010"], "unii": ["606D60IS38"], "rxcui": ["1362706", "1362712", "1362720"], "spl_set_id": ["8b20e850-037b-4c16-a57d-c3d4909f147a"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (31722-036-01)", "package_ndc": "31722-036-01", "marketing_start_date": "20221109"}], "brand_name": "Mexiletine hydrochloride", "product_id": "31722-036_ed93311a-2bfc-3875-e053-2a95a90ac6f0", "dosage_form": "CAPSULE", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "31722-036", "generic_name": "Mexiletine hydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "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": "20221109", "listing_expiration_date": "20261231"}