United States· US:68516-3610_8b01a6ae-2639-401f-9b03-45350a21e166

AlphaNine

A medicinal product, registered in United States by GRIFOLS USA, LLC.

US 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…normalisedAlphaNineATC—REGISTER NO.US:68516-3610_8b01a6a…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Manufacturer
GRIFOLS USA, 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 27, 2026

Packs & prices · 2

  • ndc11
    6851636102
    1 KIT in 1 CARTON (68516-3610-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, GLASS (76297-002-12)
  • ndc11
    68516-3610-2

Regulatory notes

No shortage, Orange Book or US label notes for this record.

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/b441b59f-0a15-4573-8c60-9f1413d5363d
GET /v1/drugs/b441b59f-0a15-4573-8c60-9f1413d5363d?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.

{
  "route": "INTRAVENOUS",
  "source": "ndc",
  "strength": null,
  "substance": null,
  "productndc": "68516-3610",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "strength_unit": null,
  "application_number": "BLA103249",
  "marketing_category": "BLA"
}

See everything about AlphaNine.

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.