FDA.reportPublic FDA data

ZURZUVAE

Product NDC
64406-030
11-digit product format
644060030
Labeler code
64406
Product ID
64406-030_c77b27a2-3351-4ec4-831c-98e20df89225
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zuranolone
Dosage form
CAPSULE
Route
ORAL
Labeler
Biogen MA Inc.
Application
NDA217369
Marketing category
NDA
Marketing start
2023-10-31
Substance
ZURANOLONE
Active strength
25 mg/1
Pharmacologic classes
GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZURZUVAE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZURANOLONE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7ZW49N180B

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
678bbbae-d295-47ce-b5bc-5810bfcf0b29Product name120231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64406-030-01ZURZUVAE1 in 1 CARTONCAPSULE117
64406-030-01ZURZUVAE14 in 1 BOTTLECAPSULE1417
64406-030-02ZURZUVAE1 in 1 CARTONCAPSULE117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-030-02EA - Each64406-0306e76bec0-a722-449b-af14-e766b30089dc12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-030ZURZUVAE (ZURANOLONE) CAPSULE [BIOGEN MA INC.]14Current NDC, 3 package rows20241120_f18e53b0-d0bb-422d-8de7-ab64b7292b29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2669910zuranolone 20 MG Oral CapsulePSNf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669918zuranolone 25 MG Oral CapsulePSNf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669922zuranolone 30 MG Oral CapsulePSNf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669916ZURZUVAE 20 MG Oral CapsulePSNf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669920ZURZUVAE 25 MG Oral CapsulePSNf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669924ZURZUVAE 30 MG Oral CapsulePSNf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669916zuranolone 20 MG Oral Capsule [Zurzuvae]SBDf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669920zuranolone 25 MG Oral Capsule [Zurzuvae]SBDf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669924zuranolone 30 MG Oral Capsule [Zurzuvae]SBDf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669910zuranolone 20 MG Oral CapsuleSCDf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669918zuranolone 25 MG Oral CapsuleSCDf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669922zuranolone 30 MG Oral CapsuleSCDf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669916Zurzuvae 20 MG Oral CapsuleSYf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669920Zurzuvae 25 MG Oral CapsuleSYf18e53b0-d0bb-422d-8de7-ab64b7292b2917
2669924Zurzuvae 30 MG Oral CapsuleSYf18e53b0-d0bb-422d-8de7-ab64b7292b2917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64406-030-01644060030011 BOTTLE in 1 CARTON (64406-030-01) / 14 CAPSULE in 1 BOTTLE1 bottle2023-10-31NoNoCurrent
64406-030-02644060030021 CARTON in 1 CARTON (64406-030-02) / 1 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK1 carton2023-10-31NoNoCurrent