Drug Database
Back to search

United States· US:64406-029_c77b27a2-3351-4ec4-831c-98e20df89225

ZURZUVAE

A zuranolone product containing zuranolone, registered in United States by Biogen MA Inc.. The same ATC class is registered in 8 of our 19 countries.

ATC N06AX31Orange 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…normalisedZURZUVAEATCN06AX31REGISTER NO.US:64406-029_c77b27a2…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about zuranoloneAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Zuranolone is registered in 8 of 19 countries.

Countries holding a registration under ATC N06AX31 (zuranolone), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 5 of them publish a price we can compare per daily dose
Search zuranolone products by name

Zuranolone · ATC N06AX31

8 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
zuranolone
Manufacturer
Biogen MA Inc.
Country
United States (US)
ATC code
N06AX31
ATC class
Zuranolone
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    6440602901
    1 BOTTLE in 1 CARTON (64406-029-01) / 14 CAPSULE in 1 BOTTLE

Regulatory notes

UNII (FDA substance ID)
7ZW49N180B
ZURANOLONE
Orange Book
N217369
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Zuranolone in 8 other countries

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

All zuranolone products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Zurzuvae
  • Liechtenstein · Zurzuvae
  • Norway · Zurzuvae

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/cd986bfb-f874-4883-b636-c3861e7cee7c
GET /v1/drugs/cd986bfb-f874-4883-b636-c3861e7cee7c?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": "7ZW49N180B",
    "rxcui": null,
    "inchikey": "HARRKNSQXBRBGZ-GVKWWOCJSA-N",
    "display_name": "ZURANOLONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f18e53b0-d0bb-422d-8de7-ab64b7292b29": {
      "match": "brand_token",
      "title": "ZURZUVAE (ZURANOLONE) CAPSULE [BIOGEN MA INC.]",
      "spl_version": "17",
      "published_date": "2026-04-27"
    }
  },
  "productid": "64406-029_c77b27a2-3351-4ec4-831c-98e20df89225",
  "productndc": "64406-029",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217369",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Oct 31, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Oct 31, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Oct 31, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZURANOLONE",
  "proprietary_name": "ZURZUVAE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217369",
  "marketing_category": "NDA",
  "nonproprietary_name": "zuranolone",
  "start_marketing_date": "20231031",
  "active_numerator_strength": "20"
}
API referenceMCP serverPlans

See everything about zuranolone.

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.

Try it freeOpen in the console