FORZINITY

Orange BookUNIISPL

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

Identification

ManufacturerStealth Biotherapeutics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7250780004
4 VIAL in 1 CARTON (72507-800-04) / 3.5 mL in 1 VIAL (72507-800-30)

Annotations

UNII (FDA Substance ID)

E40WZ3BK2D

ELAMIPRETIDE HYDROCHLORIDE

Orange Book

N215244

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "E40WZ3BK2D",
    "rxcui": null,
    "inchikey": "NGOPFUMILSNWHH-QTSNMJAOSA-N",
    "display_name": "ELAMIPRETIDE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "146bf34c-76f2-48db-ac07-fb29cce2cd75": {
      "match": "brand_token",
      "title": "FORZINITY (ELAMIPRETIDE HYDROCHLORIDE) INJECTION [STEALTH BIOTHERAPEUTICS INC.]",
      "spl_version": "10",
      "published_date": "2025-12-12"
    }
  },
  "productid": "72507-800_459e2433-fbbb-2cef-e063-6394a90a81fd",
  "productndc": "72507-800",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215244",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Sep 19, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ELAMIPRETIDE HYDROCHLORIDE",
  "proprietary_name": "FORZINITY",
  "active_ingred_unit": "mg/3.5mL",
  "application_number": "NDA215244",
  "marketing_category": "NDA",
  "nonproprietary_name": "Elamipretide Hydrochloride",
  "start_marketing_date": "20251030",
  "active_numerator_strength": "280"
}

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