FDA.reportPublic FDA data

INGREZZA

Product NDC
70370-1060
11-digit product format
703701060
Labeler code
70370
Product ID
70370-1060_bbfcd3d3-5b8b-411d-9cb6-3521a4e36e6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valbenazine
Dosage form
CAPSULE
Route
ORAL
Labeler
Neurocrine Biosciences, Inc.
Application
NDA209241
Marketing category
NDA
Marketing start
2021-04-23
Substance
VALBENAZINE TOSYLATE
Active strength
60 mg/1
Pharmacologic classes
Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALBENAZINE TOSYLATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5SML1T733B
Rxcui1918224, 1918230, 1986329, 1986331, 2054268, 2054269, 2541511, 2541513, 2665627, 2665628, 2680779, 2680780, 2680781, 2680782, 2680783, 2680784

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d2cb1284-41f6-4b6d-890e-9e251669f976Product name320250129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70370-1060-1INGREZZA30 in 1 BOTTLECAPSULE3034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70370-1060-1EA - Each70370-1060e7379b62-cc11-47e2-937a-5f1cb657cfb312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70370-1060INGREZZA (VALBENAZINE) CAPSULE INGREZZA (VALBENAZINE) KIT INGREZZA SPRINKLE (VALBENAZINE) CAPSULE [NEUROCRINE BIOSCIENCES, INC.]32Current NDC, Legacy NDC, 1 package rows20250221_4c970164-cafb-421f-9eb5-c226ef0a3417.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2665628{14 (valbenazine 40 MG Oral Capsule [Ingrezza]) / 14 (valbenazine 60 MG Oral Capsule [Ingrezza]) } Pack [Ingrezza 40/60 Initiation Pack]BPCK4c970164-cafb-421f-9eb5-c226ef0a341734
2054269{7 (valbenazine 40 MG Oral Capsule [Ingrezza]) / 21 (valbenazine 80 MG Oral Capsule [Ingrezza]) } Pack [Ingrezza]BPCK4c970164-cafb-421f-9eb5-c226ef0a341734
2665627{14 (valbenazine 40 MG Oral Capsule) / 14 (valbenazine 60 MG Oral Capsule) } PackGPCK4c970164-cafb-421f-9eb5-c226ef0a341734
2054268{7 (valbenazine 40 MG Oral Capsule) / 21 (valbenazine 80 MG Oral Capsule) } PackGPCK4c970164-cafb-421f-9eb5-c226ef0a341734
2665628INGREZZA 40 MG / 60 MG Initiation PackPSN4c970164-cafb-421f-9eb5-c226ef0a341734
2054269INGREZZA 40 MG / 80 MG Starter PackPSN4c970164-cafb-421f-9eb5-c226ef0a341734
1918230INGREZZA 40 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2541513INGREZZA 60 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
1986331INGREZZA 80 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2680780INGREZZA SPRINKLE 40 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2680782INGREZZA SPRINKLE 60 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2680784INGREZZA SPRINKLE 80 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2665627valbenazine 40 MG / 60 MG Initiation PackPSN4c970164-cafb-421f-9eb5-c226ef0a341734
2054268valbenazine 40 MG / 80 MG Starter PackPSN4c970164-cafb-421f-9eb5-c226ef0a341734
1918224valbenazine 40 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2680779valbenazine 40 MG Sprinkle Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2541511valbenazine 60 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2680781valbenazine 60 MG Sprinkle Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
1986329valbenazine 80 MG Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2680783valbenazine 80 MG Sprinkle Oral CapsulePSN4c970164-cafb-421f-9eb5-c226ef0a341734
2680780Sprinkle valbenazine 40 MG Oral Capsule [Ingrezza]SBD4c970164-cafb-421f-9eb5-c226ef0a341734
2680782Sprinkle valbenazine 60 MG Oral Capsule [Ingrezza]SBD4c970164-cafb-421f-9eb5-c226ef0a341734
2680784Sprinkle valbenazine 80 MG Oral Capsule [Ingrezza]SBD4c970164-cafb-421f-9eb5-c226ef0a341734
1918230valbenazine 40 MG Oral Capsule [Ingrezza]SBD4c970164-cafb-421f-9eb5-c226ef0a341734
2541513valbenazine 60 MG Oral Capsule [Ingrezza]SBD4c970164-cafb-421f-9eb5-c226ef0a341734
1986331valbenazine 80 MG Oral Capsule [Ingrezza]SBD4c970164-cafb-421f-9eb5-c226ef0a341734
2680779Sprinkle valbenazine 40 MG Oral CapsuleSCD4c970164-cafb-421f-9eb5-c226ef0a341734
2680781Sprinkle valbenazine 60 MG Oral CapsuleSCD4c970164-cafb-421f-9eb5-c226ef0a341734
2680783Sprinkle valbenazine 80 MG Oral CapsuleSCD4c970164-cafb-421f-9eb5-c226ef0a341734
1918224valbenazine 40 MG Oral CapsuleSCD4c970164-cafb-421f-9eb5-c226ef0a341734
2541511valbenazine 60 MG Oral CapsuleSCD4c970164-cafb-421f-9eb5-c226ef0a341734
1986329valbenazine 80 MG Oral CapsuleSCD4c970164-cafb-421f-9eb5-c226ef0a341734
1918230Ingrezza 40 MG (as valbenazine tosylate 73 MG) Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2665628INGREZZA 40 MG / 60 MG Initiation Pack, 28 capsulesSY4c970164-cafb-421f-9eb5-c226ef0a341734
2054269INGREZZA 40 MG / 80 MG Starter Pack, 28 capsulesSY4c970164-cafb-421f-9eb5-c226ef0a341734
1918230Ingrezza 40 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2541513Ingrezza 60 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
1986331Ingrezza 80 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2680780Ingrezza Sprinkle 40 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2680782Ingrezza Sprinkle 60 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2680784Ingrezza Sprinkle 80 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2680779valbenazine (as valbenazine tosylate) 40 MG Sprinkle Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2541511valbenazine (as valbenazine tosylate) 60 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2680781valbenazine (as valbenazine tosylate) 60 MG Sprinkle Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
1986329valbenazine (as valbenazine tosylate) 80 MG Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2680783valbenazine (as valbenazine tosylate) 80 MG Sprinkle Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
1918224valbenazine 40 MG (as valbenazine tosylate 73 MG) Oral CapsuleSY4c970164-cafb-421f-9eb5-c226ef0a341734
2665627valbenazine 40 MG / 60 MG Initiation Pack, 28 capsulesSY4c970164-cafb-421f-9eb5-c226ef0a341734
2054268valbenazine 40 MG / 80 MG Starter Pack, 28 capsulesSY4c970164-cafb-421f-9eb5-c226ef0a341734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70370-1060-17037010600130 CAPSULE in 1 BOTTLE (70370-1060-1) 30 capsule2021-04-230000-00-00NoNoCurrent