United States· US:67457-889_69d27b25-c8a3-434c-891d-7d5c1c495e3d

fosaprepitant

A medicinal product containing fosaprepitant, registered in United States by Mylan Institutional LLC.

In shortageOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedfosaprepitantATC—REGISTER NO.US:67457-889_69d27b25…PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
fosaprepitant
Manufacturer
Mylan Institutional LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    6745788910
    1 VIAL, SINGLE-DOSE in 1 CARTON (67457-889-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Regulatory notes

UNII (FDA substance ID)
D35FM8T64X
FOSAPREPITANT DIMEGLUMINE
RxCUI 754763
Orange Book
A204015
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fosaprepitant Dimeglumine Injection

Same medicine, other countries

Fosaprepitant in 10 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All fosaprepitant products

Authorised across Europe · EMA

The same active substance is authorised in 12 EEA countries. Names it is sold under:

  • Austria · Fosaprepitant Accord, Fosaprepitant Hikma
  • Germany · Fosaprepitant Amarox, Fosaprepitant Hikma
  • Spain · Fosaprepitant Accord, Fosaprepitant Hikma
  • Finland · Fosaprepitant Accord
  • United Kingdom (Northern Ireland) · Fosaprepitant Accord Healthcare, Fosaprepitant Amarox
  • Iceland · Ivemend
  • Italy · Fosaprepitant Accord, Fosaprepitant Hikma
  • Liechtenstein · Ivemend
  • Netherlands · Fosaprepitant Amarox
  • Norway · Fosaprepitant Accord, Ivemend
  • Portugal · Fosaprepitant Accord, Fosaprepitant Farmoz
  • Sweden · Fosaprepitant Accord

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/3122800e-860c-42ef-8381-33faf1cf1c2a
GET /v1/drugs/3122800e-860c-42ef-8381-33faf1cf1c2a?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "D35FM8T64X",
    "rxcui": "754763",
    "inchikey": "VRQHBYGYXDWZDL-OOZCZQCLSA-N",
    "display_name": "FOSAPREPITANT DIMEGLUMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "679c195a-cf59-4ca5-aa05-fa35d08ddb5c": {
      "match": "brand_token",
      "title": "FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2026-05-11"
    }
  },
  "productid": "67457-889_69d27b25-c8a3-434c-891d-7d5c1c495e3d",
  "productndc": "67457-889",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204015",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 115MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Sep 5, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 150MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Sep 5, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSAPREPITANT DIMEGLUMINE",
  "shortage_reason": "Fosaprepitant Dimeglumine Injection",
  "shortage_status": "current",
  "proprietary_name": "fosaprepitant",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204015",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fosaprepitant",
  "start_marketing_date": "20190905",
  "active_numerator_strength": "150"
}

See everything about fosaprepitant.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.