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United States · US · US:64406-030_c77b27a2-3351-4ec4-831c-98e20df89225
ZURZUVAE
Orange BookUNIISPLATC N06AX31
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBiogen MA Inc.
CountryUS (United States)
ATC codeN06AX31
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1164406030011 BOTTLE in 1 CARTON (64406-030-01) / 14 CAPSULE in 1 BOTTLE
- ndc1164406030021 CARTON in 1 CARTON (64406-030-02) / 1 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
7ZW49N180B
ZURANOLONE
Orange Book
N217369
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "64406-030_c77b27a2-3351-4ec4-831c-98e20df89225",
"productndc": "64406-030",
"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": "25"
}Related drugs
Other records sharing ATC code N06AX31.
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