Matulane

Orange BookUNIISPLATC L01XB01

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

Identification

ManufacturerLeadiant Biosciences, Inc.

CountryUS (United States)

ATC codeL01XB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5448205401
100 CAPSULE in 1 BOTTLE (54482-054-01)

Annotations

UNII (FDA Substance ID)

XH0NPH5ZX8

PROCARBAZINE HYDROCHLORIDE

RxCUI 66925

Orange Book

N016785

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "XH0NPH5ZX8",
    "rxcui": "66925",
    "inchikey": "DERJYEZSLHIUKF-UHFFFAOYSA-N",
    "display_name": "PROCARBAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1aa75a3a-18c9-49e1-91a6-293d0b7da756": {
      "match": "brand_token",
      "title": "MATULANE (PROCARBAZINE HYDROCHLORIDE) CAPSULE [LEADIANT BIOSCIENCES, INC.]",
      "spl_version": "9",
      "published_date": "2024-09-25"
    }
  },
  "productid": "54482-054_caa705fa-c467-49b5-a7cb-ae2c8b872a86",
  "productndc": "54482-054",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "016785",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROCARBAZINE HYDROCHLORIDE",
  "proprietary_name": "Matulane",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA016785",
  "marketing_category": "NDA",
  "nonproprietary_name": "procarbazine hydrochloride",
  "start_marketing_date": "19851227",
  "active_numerator_strength": "50"
}

Related drugs

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