AVMAPKI FAKZYNJA CO-PACK

Orange BookSPL

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

Identification

ManufacturerVerastem Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7177962301
1 KIT in 1 CARTON (71779-623-01) * 24 CAPSULE in 1 BOTTLE (71779-660-02) * 42 TABLET in 1 BOTTLE (71779-630-01)

Annotations

Orange Book

N219616

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "65889527-1406-45df-8a85-e2690dcf427d": {
      "match": "brand_token",
      "title": "AVMAPKI FAKZYNJA CO-PACK (AVUTOMETINIB POTASSIUM AND DEFACTINIB HYDROCHLORIDE) KIT [VERASTEM INC.]",
      "spl_version": "2",
      "published_date": "2025-05-23"
    }
  },
  "productid": "71779-623_e6def323-179c-432e-957d-fc4ea03e1b78",
  "productndc": "71779-623",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "219616",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.8MG BASE;EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "May 8, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "AVMAPKI FAKZYNJA CO-PACK",
  "active_ingred_unit": null,
  "application_number": "NDA219616",
  "marketing_category": "NDA",
  "nonproprietary_name": "avutometinib potassium and defactinib hydrochloride",
  "start_marketing_date": "20250508",
  "active_numerator_strength": null
}

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