Mexiletine Hydrochloride

Orange BookUNIISPLATC C01BB02

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

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeC01BB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6498066801
100 CAPSULE in 1 BOTTLE (64980-668-01)

Annotations

UNII (FDA Substance ID)

606D60IS38

MEXILETINE HYDROCHLORIDE

RxCUI 142138

Orange Book

A215315

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": "64980-668_17c65cba-f56f-4cad-a9e2-d31f62e95849",
  "productndc": "64980-668",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215315",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Aug 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Aug 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "Aug 26, 2022"
      }
    ],
    "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": "ANDA215315",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mexiletine Hydrochloride",
  "start_marketing_date": "20250205",
  "active_numerator_strength": "250"
}

Related drugs

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