ZURZUVAE
These highlights do not include all the information needed to use ZURZUVAE safely and effectively. See full prescribing information for ZURZUVAE. ZURZUVAE (zuranolone) capsules, for oral use, CIVInitial U.S. Approval: 2023
Approved
Approval ID
f18e53b0-d0bb-422d-8de7-ab64b7292b29
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Biogen MA Inc.
DUNS: 121376230
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
zuranolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-029
Application NumberNDA217369
Product Classification
M
Marketing Category
C73594
G
Generic Name
zuranolone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2023
FDA Product Classification
INGREDIENTS (6)
ZURANOLONEActive
Quantity: 20 mg in 1 1
Code: 7ZW49N180B
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Quantity: 26.19 mg in 1 1
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Quantity: 105.92 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 1.667 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Quantity: 10.002 mg in 1 1
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Quantity: 2.9175 mg in 1 1
Code: 7CV7WJK4UI
Classification: IACT
zuranolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-031
Application NumberNDA217369
Product Classification
M
Marketing Category
C73594
G
Generic Name
zuranolone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2023
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Quantity: 39.28 mg in 1 1
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Quantity: 158.85 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
ZURANOLONEActive
Quantity: 30 mg in 1 1
Code: 7ZW49N180B
Classification: ACTIM
SILICON DIOXIDEInactive
Quantity: 2.5 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Quantity: 15 mg in 1 1
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Quantity: 4.375 mg in 1 1
Code: 7CV7WJK4UI
Classification: IACT
zuranolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-030
Application NumberNDA217369
Product Classification
M
Marketing Category
C73594
G
Generic Name
zuranolone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2023
FDA Product Classification
INGREDIENTS (6)
ZURANOLONEActive
Quantity: 25 mg in 1 1
Code: 7ZW49N180B
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Quantity: 32.72 mg in 1 1
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Quantity: 132.35 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 2.084 mg in 1 1
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Quantity: 12.503 mg in 1 1
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Quantity: 3.646 mg in 1 1
Code: 7CV7WJK4UI
Classification: IACT