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INGREZZA Sprinkle

Valbenazine · Capsule

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
INGREZZA Sprinkle
Generic name
Valbenazine
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
Neurocrine Biosciences, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Valbenazine Tosylate 40 mg/1 1918224 View
Valbenazine Tosylate 60 mg/1 1918224 View
Valbenazine Tosylate 80 mg/1 1918224 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Vesicular Monoamine Transporter 2 Inhibitor [EPC] EPC 5 members — no class page
Vesicular Monoamine Transporter 2 Inhibitors [MoA] MoA 5 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
218390
Application type
NDA · New Drug Application
Approval date
April 30, 2024
Sponsor
NEUROCRINE
Products on application
3
Submissions recorded
2
Products approved under application 218390.
Product Trade name Form Strength Ingredient Status TE Flags
218390-001 INGREZZA SPRINKLE CAPSULE VALBENAZINE TOSYLATE Prescription — RLD
218390-002 INGREZZA SPRINKLE CAPSULE VALBENAZINE TOSYLATE Prescription — RLD
218390-003 INGREZZA SPRINKLE CAPSULE VALBENAZINE TOSYLATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8357697 November 8, 2027 001 No U-1995 May 13, 2024
8357697 November 8, 2027 001 No U-3055 May 13, 2024
8357697 November 8, 2027 002 No U-3055 May 13, 2024
8357697 November 8, 2027 002 No U-1995 May 13, 2024
8357697 November 8, 2027 003 No U-3055 May 13, 2024
8357697 November 8, 2027 003 No U-1995 May 13, 2024
8039627 April 11, 2031 001 Yes May 13, 2024
8039627 April 11, 2031 002 Yes May 13, 2024
8039627 April 11, 2031 003 Yes May 13, 2024
10851104 October 28, 2036 001 Yes U-1995 May 13, 2024
10851104 October 28, 2036 001 Yes U-3055 May 13, 2024
10851103 October 28, 2036 001 Yes U-1995 May 13, 2024
10851103 October 28, 2036 001 Yes U-3055 May 13, 2024
10844058 October 28, 2036 001 Yes U-1995 May 13, 2024
10844058 October 28, 2036 001 Yes U-3055 May 13, 2024
10065952 October 28, 2036 001 Yes U-1995 May 13, 2024
10065952 October 28, 2036 001 Yes U-3055 May 13, 2024
10851104 October 28, 2036 002 Yes U-3055 May 13, 2024
10851104 October 28, 2036 002 Yes U-1995 May 13, 2024
10851103 October 28, 2036 002 Yes U-3055 May 13, 2024
10851103 October 28, 2036 002 Yes U-1995 May 13, 2024
10844058 October 28, 2036 002 Yes U-3055 May 13, 2024
10844058 October 28, 2036 002 Yes U-1995 May 13, 2024
10065952 October 28, 2036 002 Yes U-3055 May 13, 2024
10065952 October 28, 2036 002 Yes U-1995 May 13, 2024
10851104 October 28, 2036 003 Yes U-3055 May 13, 2024
10851104 October 28, 2036 003 Yes U-1995 May 13, 2024
10851103 October 28, 2036 003 Yes U-3055 May 13, 2024
10851103 October 28, 2036 003 Yes U-1995 May 13, 2024
10844058 October 28, 2036 003 Yes U-3055 May 13, 2024
10844058 October 28, 2036 003 Yes U-1995 May 13, 2024
10065952 October 28, 2036 003 Yes U-3055 May 13, 2024
10065952 October 28, 2036 003 Yes U-1995 May 13, 2024
10906903 December 22, 2036 001 Yes May 13, 2024
10919892 December 22, 2036 001 Yes May 13, 2024
10906902 December 22, 2036 001 Yes May 13, 2024
10919892 December 22, 2036 002 Yes May 13, 2024
10906902 December 22, 2036 002 Yes May 13, 2024
10906903 December 22, 2036 002 Yes May 13, 2024
10906903 December 22, 2036 003 Yes May 13, 2024
10919892 December 22, 2036 003 Yes May 13, 2024
10906902 December 22, 2036 003 Yes May 13, 2024
11439629 October 10, 2037 001 No U-3055 May 13, 2024
11040029 October 10, 2037 001 No U-1995 May 13, 2024
10993941 October 10, 2037 001 No U-1995 May 13, 2024
10952997 October 10, 2037 001 No U-1995 May 13, 2024
10912771 October 10, 2037 001 No U-1995 May 13, 2024
10912771 October 10, 2037 001 No U-3076 May 13, 2024
10912771 October 10, 2037 001 No U-3055 May 13, 2024
10874648 October 10, 2037 001 No U-1995 May 13, 2024
10874648 October 10, 2037 001 No U-3055 May 13, 2024
10874648 October 10, 2037 001 No U-3046 May 13, 2024
10857148 October 10, 2037 001 No U-1995 May 13, 2024
10857137 October 10, 2037 001 No U-1995 May 13, 2024
11439629 October 10, 2037 002 No U-3055 May 13, 2024
11040029 October 10, 2037 002 No U-1995 May 13, 2024
10993941 October 10, 2037 002 No U-1995 May 13, 2024
10952997 October 10, 2037 002 No U-1995 May 13, 2024
10912771 October 10, 2037 002 No U-3076 May 13, 2024
10912771 October 10, 2037 002 No U-3055 May 13, 2024
10912771 October 10, 2037 002 No U-1995 May 13, 2024
10874648 October 10, 2037 002 No U-3055 May 13, 2024
10874648 October 10, 2037 002 No U-3046 May 13, 2024
10874648 October 10, 2037 002 No U-1995 May 13, 2024
10857148 October 10, 2037 002 No U-1995 May 13, 2024
10857137 October 10, 2037 002 No U-1995 May 13, 2024
11439629 October 10, 2037 003 No U-3055 May 13, 2024
11040029 October 10, 2037 003 No U-1995 May 13, 2024
10993941 October 10, 2037 003 No U-1995 May 13, 2024
10952997 October 10, 2037 003 No U-1995 May 13, 2024
10912771 October 10, 2037 003 No U-3076 May 13, 2024
10912771 October 10, 2037 003 No U-3055 May 13, 2024
10912771 October 10, 2037 003 No U-1995 May 13, 2024
10874648 October 10, 2037 003 No U-3055 May 13, 2024
10874648 October 10, 2037 003 No U-3046 May 13, 2024
10874648 October 10, 2037 003 No U-1995 May 13, 2024
10857148 October 10, 2037 003 No U-1995 May 13, 2024
10857137 October 10, 2037 003 No U-1995 May 13, 2024
11311532 September 18, 2038 001 No U-1995 May 13, 2024
11311532 September 18, 2038 001 No U-3055 May 13, 2024
11026939 September 18, 2038 001 No U-1995 May 13, 2024
11026939 September 18, 2038 001 No U-3055 May 13, 2024
11311532 September 18, 2038 002 No U-3055 May 13, 2024
11311532 September 18, 2038 002 No U-1995 May 13, 2024
11026939 September 18, 2038 002 No U-3055 May 13, 2024
11026939 September 18, 2038 002 No U-1995 May 13, 2024
11311532 September 18, 2038 003 No U-3055 May 13, 2024
11311532 September 18, 2038 003 No U-1995 May 13, 2024
11026939 September 18, 2038 003 No U-3055 May 13, 2024
11026939 September 18, 2038 003 No U-1995 May 13, 2024
11654142 November 14, 2038 001 No U-3055 May 13, 2024
11654142 November 14, 2038 002 No U-3055 May 13, 2024
11654142 November 14, 2038 003 No U-3055 May 13, 2024
11026931 August 14, 2039 001 No U-1995 May 13, 2024
11026931 August 14, 2039 002 No U-1995 May 13, 2024
11026931 August 14, 2039 003 No U-1995 May 13, 2024
10940141 August 10, 2040 001 No U-1995 May 13, 2024
10940141 August 10, 2040 002 No U-1995 May 13, 2024
10940141 August 10, 2040 003 No U-1995 May 13, 2024
Regulatory exclusivity periods.
Code Expires Product
I-925 August 18, 2026 001
I-925 August 18, 2026 002
I-925 August 18, 2026 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 218390.
Type No. Action Status Date Review
Supplement 3 Labeling Approved April 8, 2026 Standard
Original application 1 Type 3 - New Dosage Form Approved April 30, 2024 Standard

Review documents

  • 0 · Supplement · June 29, 2026
  • 0 · Supplement · April 9, 2026
  • 0 · Original application · May 1, 2025
  • 0 · Original application · July 23, 2024
  • 0 · Original application · May 2, 2024
  • 0 · Original application · May 1, 2024

Adverse event reports

Source: openFDA FAERS
25,010
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: VALBENAZINE TOSYLATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
70370-4040-1 70370-4040 Neurocrine Biosciences, Inc. 30 CAPSULE in 1 BOTTLE (70370-4040-1) April 30, 2024
70370-4060-1 70370-4060 Neurocrine Biosciences, Inc. 30 CAPSULE in 1 BOTTLE (70370-4060-1) April 30, 2024
70370-4080-1 70370-4080 Neurocrine Biosciences, Inc. 30 CAPSULE in 1 BOTTLE (70370-4080-1) April 30, 2024
70370-4040 70370-4040 Neurocrine Biosciences, Inc. — April 30, 2024
70370-4060 70370-4060 Neurocrine Biosciences, Inc. — April 30, 2024
70370-4080 70370-4080 Neurocrine Biosciences, Inc. — April 30, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.