Mexiletine Hydrochloride

Orange BookUNIISPLATC C01BB02

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC01BB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3334255611
100 CAPSULE in 1 CONTAINER (33342-556-11)
ndc11
3334255612
10 BLISTER PACK in 1 CARTON (33342-556-12) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

606D60IS38

MEXILETINE HYDROCHLORIDE

RxCUI 142138

Orange Book

A219987

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": "33342-556_a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1",
  "productndc": "33342-556",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219987",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Mar 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Mar 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "003",
        "approval_date": "Mar 23, 2026"
      }
    ],
    "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": "ANDA219987",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mexiletine Hydrochloride",
  "start_marketing_date": "20260323",
  "active_numerator_strength": "200"
}

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