ALECENSA

Orange BookUNIISPLATC L01ED03

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

Identification

ManufacturerGenentech, Inc.

CountryUS (United States)

ATC codeL01ED03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5024213001
1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC
ndc11
5024213086
1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

P9YY73LO6J

ALECTINIB HYDROCHLORIDE

RxCUI 1727454

Orange Book

N208434

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P9YY73LO6J",
    "rxcui": "1727454",
    "inchikey": "GYABBVHSRIHYJR-UHFFFAOYSA-N",
    "display_name": "ALECTINIB HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "42c49deb-713b-427a-9670-08af08adcffb": {
      "match": "brand_token",
      "title": "ALECENSA (ALECTINIB HYDROCHLORIDE) CAPSULE [GENENTECH, INC.]",
      "spl_version": "27",
      "published_date": "2025-12-18"
    }
  },
  "productid": "50242-130_abdb3f90-4a44-4404-a49c-8d3bbc4dd13b",
  "productndc": "50242-130",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208434",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Dec 11, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALECTINIB HYDROCHLORIDE",
  "proprietary_name": "ALECENSA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208434",
  "marketing_category": "NDA",
  "nonproprietary_name": "ALECTINIB HYDROCHLORIDE",
  "start_marketing_date": "20151211",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code L01ED03.

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