Crenessity

In shortageOrange BookUNIISPL

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

Identification

ManufacturerNeurocrine Biosciences, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7037050501
60 CAPSULE in 1 BOTTLE (70370-5050-1)

Annotations

UNII (FDA Substance ID)

MFT24BX55I

CRINECERFONT

Orange Book

N218808

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Crinecerfont Capsule

Raw payload (JSON)

{
  "unii": {
    "unii": "MFT24BX55I",
    "rxcui": null,
    "inchikey": "IEAKXXNRGSLYTQ-DEOSSOPVSA-N",
    "display_name": "CRINECERFONT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fd3a6fbd-9137-428a-ba46-df6606f07d28": {
      "match": "brand_token",
      "title": "CRENESSITY (CRINECERFONT) CAPSULE CRENESSITY (CRINECERFONT) SOLUTION [NEUROCRINE BIOSCIENCES, INC.]",
      "spl_version": "5",
      "published_date": "2025-02-13"
    }
  },
  "productid": "70370-5050_f5cc43fd-6e18-4a06-8c9f-bd80ea847e83",
  "productndc": "70370-5050",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218808",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Dec 13, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Dec 13, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Dec 13, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CRINECERFONT",
  "shortage_reason": "Crinecerfont Capsule",
  "shortage_status": "current",
  "proprietary_name": "Crenessity",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218808",
  "marketing_category": "NDA",
  "nonproprietary_name": "crinecerfont",
  "start_marketing_date": "20241213",
  "active_numerator_strength": "50"
}

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