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INGREZZA

These highlights do not include all the information needed to use INGREZZA safely and effectively. See full prescribing information for INGREZZA. INGREZZA (valbenazine) capsules, for oral use Initial U.S. Approval: 2017

Approved
Approval ID

4c970164-cafb-421f-9eb5-c226ef0a3417

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 18, 2023

Manufacturers
FDA

Neurocrine Biosciences, Inc.

DUNS: 800981276

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Valbenazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70370-2040
Application NumberNDA209241
Product Classification
M
Marketing Category
C73594
G
Generic Name
Valbenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (9)

FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
VALBENAZINE TOSYLATEActive
Quantity: 40 mg in 1 1
Code: 5SML1T733B
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ISOMALTInactive
Code: S870P55O2W
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Valbenazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70370-1060
Application NumberNDA209241
Product Classification
M
Marketing Category
C73594
G
Generic Name
Valbenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (9)

VALBENAZINE TOSYLATEActive
Quantity: 60 mg in 1 1
Code: 5SML1T733B
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ISOMALTInactive
Code: S870P55O2W
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Valbenazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70370-2048
Application NumberNDA209241
Product Classification
M
Marketing Category
C73594
G
Generic Name
Valbenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

Valbenazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70370-1080
Application NumberNDA209241
Product Classification
M
Marketing Category
C73594
G
Generic Name
Valbenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

INGREDIENTS (9)

GELATINInactive
Code: 2G86QN327L
Classification: IACT
VALBENAZINE TOSYLATEActive
Quantity: 80 mg in 1 1
Code: 5SML1T733B
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ISOMALTInactive
Code: S870P55O2W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT

Valbenazine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70370-2046
Application NumberNDA209241
Product Classification
M
Marketing Category
C73594
G
Generic Name
Valbenazine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification

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INGREZZA - FDA Drug Approval Details