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United States · US · US:50419-475_440713bb-71c2-4ed9-b3d6-e2c138f088d0

LYNKUET

Orange BookUNIISPLATC G02CX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG02CX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5041947505
    5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01)
  • ndc11
    5041947572
    2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)
  • ndc11
    5041947573
    1 BLISTER PACK in 1 CARTON (50419-475-73) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71)

Annotations

UNII (FDA Substance ID)
NZW2BOW35N
ELINZANETANT
Orange Book
N219469
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NZW2BOW35N",
    "rxcui": null,
    "inchikey": "DWRIJNIPBUFCQS-DQEYMECFSA-N",
    "display_name": "ELINZANETANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f42884ff-7dff-419c-8a0c-affe2ed73818": {
      "match": "brand_token",
      "title": "LYNKUET (ELINZANETANT) CAPSULE [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "9",
      "published_date": "2026-05-11"
    }
  },
  "productid": "50419-475_440713bb-71c2-4ed9-b3d6-e2c138f088d0",
  "productndc": "50419-475",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219469",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Oct 24, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELINZANETANT",
  "proprietary_name": "LYNKUET",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219469",
  "marketing_category": "NDA",
  "nonproprietary_name": "elinzanetant",
  "start_marketing_date": "20251024",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code G02CX.

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