Mexiletine Hydrochloride

Orange BookUNIISPLATC C01BB02

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

Identification

ManufacturerGolden State Medical Supply, Inc.

CountryUS (United States)

ATC codeC01BB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5140737901
100 CAPSULE in 1 BOTTLE (51407-379-01)

Annotations

UNII (FDA Substance ID)

606D60IS38

MEXILETINE HYDROCHLORIDE

RxCUI 142138

Orange Book

A074450

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": "51407-379_45b6d529-143e-2322-e063-6294a90a65a5",
  "productndc": "51407-379",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "074450",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "May 16, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "May 16, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "May 16, 1996"
      }
    ],
    "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": "ANDA074450",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mexiletine Hydrochloride",
  "start_marketing_date": "19960516",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code C01BB02.

Access this data programmatically

Query Mexiletine Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs