ENSACOVE

Orange BookUNIISPL

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

Identification

ManufacturerXcovery Holdings, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8307611006
60 CAPSULE in 1 BOTTLE (83076-1100-6)

Annotations

UNII (FDA Substance ID)

C2FR6VT1BQ

ENSARTINIB HYDROCHLORIDE

Orange Book

N218171

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "C2FR6VT1BQ",
    "rxcui": null,
    "inchikey": "IERUINQRGJAECT-ISUJJMBGSA-N",
    "display_name": "ENSARTINIB HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1e1b2f79-678a-472a-b924-66909c8a4b2e": {
      "match": "brand_token",
      "title": "ENSACOVE (ENSARTINIB) CAPSULE [XCOVERY HOLDINGS, INC.]",
      "spl_version": "5",
      "published_date": "2026-02-26"
    }
  },
  "productid": "83076-1100_17196ce1-224e-4359-ac54-39e035def74f",
  "productndc": "83076-1100",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218171",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Dec 18, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Dec 18, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENSARTINIB HYDROCHLORIDE",
  "proprietary_name": "ENSACOVE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218171",
  "marketing_category": "NDA",
  "nonproprietary_name": "ensartinib",
  "start_marketing_date": "20250430",
  "active_numerator_strength": "100"
}

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