zurzuvae

Generic: zuranolone

Labeler: biogen ma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zurzuvae
Generic Name zuranolone
Labeler biogen ma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zuranolone 30 mg/1

Manufacturer
Biogen MA Inc.

Identifiers & Regulatory

Product NDC 64406-031
Product ID 64406-031_61d04f88-eafb-40e4-ac63-62d083d14acf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217369
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2023-10-31

Pharmacologic Class

Established (EPC)
neuroactive steroid gamma-aminobutyric acid a receptor positive modulator [epc]
Mechanism of Action
gaba a receptor positive modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64406031
Hyphenated Format 64406-031

Supplemental Identifiers

RxCUI
2669910 2669916 2669918 2669920 2669922 2669924
UNII
7ZW49N180B
NUI
N0000194006 N0000193997

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zurzuvae (source: ndc)
Generic Name zuranolone (source: ndc)
Application Number NDA217369 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (64406-031-01) / 14 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

64406-031-01 1 BOTTLE in 1 CARTON (64406-031-01) / 14 CAPSULE in 1 BOTTLE

Ingredients (1)

zuranolone (30 mg/1)

Linked Drug Pages (1)

ZURZUVAE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "61d04f88-eafb-40e4-ac63-62d083d14acf", "openfda": {"nui": ["N0000194006", "N0000193997"], "unii": ["7ZW49N180B"], "rxcui": ["2669910", "2669916", "2669918", "2669920", "2669922", "2669924"], "spl_set_id": ["f18e53b0-d0bb-422d-8de7-ab64b7292b29"], "pharm_class_epc": ["Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "pharm_class_moa": ["GABA A Receptor Positive Modulators [MoA]"], "manufacturer_name": ["Biogen MA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (64406-031-01)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "64406-031-01", "marketing_start_date": "20231031"}], "brand_name": "ZURZUVAE", "product_id": "64406-031_61d04f88-eafb-40e4-ac63-62d083d14acf", "dosage_form": "CAPSULE", "pharm_class": ["GABA A Receptor Positive Modulators [MoA]", "Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"], "product_ndc": "64406-031", "dea_schedule": "CIV", "generic_name": "zuranolone", "labeler_name": "Biogen MA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZURZUVAE", "active_ingredients": [{"name": "ZURANOLONE", "strength": "30 mg/1"}], "application_number": "NDA217369", "marketing_category": "NDA", "marketing_start_date": "20231031", "listing_expiration_date": "20271231"}