VALCHLOR

Orange BookUNIISPLATC L01AA05

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

Identification

ManufacturerHelsinn Therapeutics (U.S.), Inc.

CountryUS (United States)

ATC codeL01AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6963912001
1 TUBE in 1 CARTON (69639-120-01) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

50D9XSG0VR

MECHLORETHAMINE

RxCUI 6674

Orange Book

N202317

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "50D9XSG0VR",
    "rxcui": "6674",
    "inchikey": "HAWPXGHAZFHHAD-UHFFFAOYSA-N",
    "display_name": "MECHLORETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57": {
      "match": "brand_token",
      "title": "VALCHLOR (MECHLORETHAMINE HYDROCHLORIDE) GEL [HELSINN THERAPEUTICS (U.S.), INC.]",
      "spl_version": "12",
      "published_date": "2024-11-25"
    }
  },
  "productid": "69639-120_942707af-a16c-4a62-b733-103e0fac915e",
  "productndc": "69639-120",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "202317",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.016% BASE",
        "product_no": "001",
        "approval_date": "Aug 23, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MECHLORETHAMINE",
  "proprietary_name": "VALCHLOR",
  "active_ingred_unit": "g/60g",
  "application_number": "NDA202317",
  "marketing_category": "NDA",
  "nonproprietary_name": "mechlorethamine hydrochloride",
  "start_marketing_date": "20181108",
  "active_numerator_strength": ".012"
}

Related drugs

Other records sharing ATC code L01AA05.

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