Yorvipath

Orange BookUNIISPLATC H05AA05

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

Identification

ManufacturerAscendis Pharma, Endocrinology, Inc.

CountryUS (United States)

ATC codeH05AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7336210201
2 BOX in 1 CARTON (73362-102-01) / 1 SYRINGE in 1 BOX (73362-102-02) / 1 CARTRIDGE in 1 SYRINGE (73362-102-03) / 1.4 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)

G2N64C3385

PALOPEGTERIPARATIDE

Orange Book

N216490

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "G2N64C3385",
    "rxcui": null,
    "inchikey": null,
    "display_name": "PALOPEGTERIPARATIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "a1fa23fd-c434-443e-9a17-5750578c8602": {
      "match": "brand_token",
      "title": "YORVIPATH (PALOPEGTERIPARATIDE) INJECTION, SOLUTION [ASCENDIS PHARMA, ENDOCRINOLOGY, INC.]",
      "spl_version": "7",
      "published_date": "2026-04-30"
    }
  },
  "productid": "73362-102_eb81bad9-a369-4eeb-a69e-6920924381b9",
  "productndc": "73362-102",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216490",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)",
        "product_no": "001",
        "approval_date": "Aug 9, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)",
        "product_no": "002",
        "approval_date": "Aug 9, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)",
        "product_no": "003",
        "approval_date": "Aug 9, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALOPEGTERIPARATIDE",
  "proprietary_name": "Yorvipath",
  "active_ingred_unit": "ug/1.4mL",
  "application_number": "NDA216490",
  "marketing_category": "NDA",
  "nonproprietary_name": "Palopegteriparatide",
  "start_marketing_date": "20240809",
  "active_numerator_strength": "420"
}

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