Mexiletine Hydrochloride

Orange BookUNIISPLATC C01BB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvKARE

CountryUS (United States)

ATC codeC01BB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4229162601
100 CAPSULE in 1 BOTTLE (42291-626-01)

Annotations

UNII (FDA Substance ID)

606D60IS38

MEXILETINE HYDROCHLORIDE

RxCUI 142138

Orange Book

A074377

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "606D60IS38",
    "rxcui": "142138",
    "inchikey": "NFEIBWMZVIVJLQ-UHFFFAOYSA-N",
    "display_name": "MEXILETINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1": {
      "match": "brand_token",
      "title": "MEXILETINE HYDROCHLORIDE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "1",
      "published_date": "2026-04-17"
    }
  },
  "productid": "42291-626_4870f872-0804-7f08-e063-6394a90a19e9",
  "productndc": "42291-626",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "074377",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "May 16, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "May 16, 1995"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "May 16, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEXILETINE HYDROCHLORIDE",
  "proprietary_name": "Mexiletine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074377",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mexiletine Hydrochloride",
  "start_marketing_date": "20130709",
  "active_numerator_strength": "250"
}

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