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INGREZZA Valbenazine Kit, 1 kit — NDC 70370-2048-06 package photo

INGREZZA Valbenazine Kit, 1 kit

by Neurocrine Biosciences, Inc. · 1 BLISTER PACK in 1 CARTON (70370-2048-6) / 1 KIT in 1 BLISTER PACK
NDC 70370-2048-06
🏷️ FDA NDC (as labeled) 70370-2048-6 billing pads the package segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 70370-2048-6
Product NDC 70370-2048
11-digit billing NDC 70370204806
NCPDP billing unit EA — each (per item)
RxCUI 1918224, 1918230, 1986329, 1986331, 2054268, 2054269, 2541511, 2541513,
UNII 5SML1T733B
UPC 0370370408011, 0370370404013, 0370370204019, 0370370108010 +2 more
Application # NDA209241
SPL Set ID 4c970164-cafb-421f-9eb5-c226ef0a3417
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-14
Route ORAL
Dosage form KIT
GPI-14 6238008020B220
GPI class Ingrezza
GCN Seq No 079676
GCN 46216
HICL code 044202
Ingredient (HICL) Valbenazine Tosylate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6L
Therapeutic class — specific (HIC3) Drugs To Treat Movement Disorders
AHFS code 28:56.00.00
AHFS class Vesicular Monoamine Transport2 Inhibitor
FDB label name INGREZZA INITIATION PK(TARDIV)
FDB brand name Ingrezza Initiation Pk(Tardiv)
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70370-2048-6 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70370-2048-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Vesicular Monoamine Transporter 2 Inhibitor class.

Pharmacologic class Vesicular Monoamine Transporter 2 Inhibitor
Drug family (ATC) Other nervous system drugs
How it works Vesicular Monoamine Transporter 2 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNeurocrine Biosciences, Inc.
Application holderNEUROCRINE BIOSCIENCES INC
FDA applicationNDA209241 (NDA)
Labeler code70370
First marketedDec 2018
Product typeHuman Prescription Drug
Portfolio12 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name INGREZZA INITIATION PK(TARDIV) Ingredient Valbenazine Tosylate
📖 What it is MedlinePlus · NLM

Valbenazine is used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts) and chorea (sudden movements that you cannot control) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). Valbenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Valbenazine is designed to reduce the uncontrolled, involuntary movements that can be really disruptive to daily life. If you have tardive dyskinesia — those repetitive facial or b...
  • What exactly is this medication supposed to do for me?
  • Yes, drowsiness is the most commonly reported side effect — so this is worth planning for. Some people find it quite manageable, while others feel it more strongly, especially when...
  • Yes, and this is really important. Valbenazine carries a serious warning specifically for people with Huntington's disease: it can increase the risk of depression and suicidal thou...
📖 Read our full Valbenazine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white / purple / red
ShapeCapsule
ImprintVBZ;80
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

The FDA label contains product information, but this exact NDC could not be matched safely to one product block. We intentionally withheld sibling strengths’ ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $308.01 $308.01 / 1 kit
Medicare drug plans payPart D · Q2 2026 $315.20 $315.20 / 1 kit
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ingrezza 70370-2046-01 Neurocrine 1 kit — AB FDA listed —
Ingrezzathis 70370-2048-06 Neurocrine 1 kit — AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2017
First FDA approval
Oct 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2040
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 4, 2017 AB TE-rated RLD RS ⏳ ~13.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10065952 — drug substance (U-1995)
US 8357697 — method of use (U-1995)
US 10874648 — method of use (U-1995)
US 10874648 — method of use (U-3046)
US 10874648 — method of use (U-1995)
US 10874648 — method of use (U-3046)
US 11311532 — method of use (U-1995)
US 11311532 — method of use (U-1995)
US 11311532 — method of use (U-1995)
US 10857137 — method of use (U-1995)
US 10857148 — method of use (U-1995)
US 10844058 — drug substance (U-1995)
US 10851103 — drug substance (U-1995)
US 10851104 — drug substance (U-1995)
US 10851104 — drug substance (U-1995)
US 10857148 — method of use (U-1995)
US 10851103 — drug substance (U-1995)
US 10857137 — method of use (U-1995)
US 10844058 — drug substance (U-1995)
US 10952997 — method of use (U-1995)
US 10940141 — method of use (U-1995)
US 10952997 — method of use (U-1995)
US 10940141 — method of use (U-1995)
US 11654142 — method of use (U-3055)
US 11654142 — method of use (U-3055)
US 11654142 — method of use (U-3055)
US 11439629 — method of use (U-3055)
US 11439629 — method of use (U-3055)
US 11439629 — method of use (U-3055)
US 11311532 — method of use (U-3055)
US 11311532 — method of use (U-3055)
US 11311532 — method of use (U-3055)
US 10065952 — drug substance (U-1995)
US 11026939 — method of use (U-3055)
US 11026939 — method of use (U-3055)
US 11026939 — method of use (U-3055)
US 10912771 — method of use (U-3055)
US 10912771 — method of use (U-3055)
US 10912771 — method of use (U-3055)
US 10874648 — method of use (U-3055)
US 10874648 — method of use (U-3055)
US 10874648 — method of use (U-3055)
US 10851104 — drug substance (U-3055)
US 10851104 — drug substance (U-3055)
US 10851104 — drug substance (U-3055)
US 10851103 — drug substance (U-3055)
US 10851103 — drug substance (U-3055)
US 10851103 — drug substance (U-3055)
US 10844058 — drug substance (U-3055)
US 10844058 — drug substance (U-3055)
US 10844058 — drug substance (U-3055)
US 10065952 — drug substance (U-3055)
US 10065952 — drug substance (U-3055)
US 10065952 — drug substance (U-3055)
US 8357697 — method of use (U-3055)
US 8357697 — method of use (U-3055)
US 8357697 — method of use (U-3055)
US 8357697 — method of use (U-1995)
US 10851104 — drug substance (U-1995)
US 10844058 — drug substance (U-1995)
US 10851103 — drug substance (U-1995)
US 10857137 — method of use (U-1995)
US 10065952 — drug substance (U-1995)
US 10857148 — method of use (U-1995)
US 10874648 — method of use (U-1995)
US 10874648 — method of use (U-3046)
US 10912771 — method of use (U-3076)
US 10912771 — method of use (U-1995)
US 10993941 — method of use (U-1995)
US 10940141 — method of use (U-1995)
US 8357697 — method of use (U-1995)
US 10952997 — method of use (U-1995)
US 10993941 — method of use (U-1995)
US 10993941 — method of use (U-1995)
US 11026931 — method of use (U-1995)
US 11026939 — method of use (U-1995)
US 11040029 — method of use (U-1995)
US 11026931 — method of use (U-1995)
US 11026939 — method of use (U-1995)
US 11040029 — method of use (U-1995)
US 11026931 — method of use (U-1995)
US 11040029 — method of use (U-1995)
US 11026939 — method of use (U-1995)
US 10912771 — method of use (U-1995)
US 10912771 — method of use (U-3076)
US 10912771 — method of use (U-1995)
US 10912771 — method of use (U-3076)
US 10906902 — drug substance
US 8039627 — drug substance
US 10919892 — drug substance
US 10919892 — drug substance
US 10906903 — drug substance
US 10906902 — drug substance
US 8039627 — drug substance
US 10906902 — drug substance
US 10906903 — drug substance
US 10919892 — drug substance
US 8039627 — drug substance
US 10906903 — drug substance
Exclusivity I-925
Exclusivity ODE-440
Exclusivity I-925
Exclusivity ODE-440
Exclusivity I-925
Exclusivity ODE-440
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (99)
PatentTypeUse codeExpires
US 10065952 ↗ Drug substance U-1995 Oct 28, 2036
US 8357697 ↗ Method of use U-1995 Nov 8, 2027
US 10874648 ↗ Method of use U-1995 Oct 10, 2037
US 10874648 ↗ Method of use U-3046 Oct 10, 2037
US 10874648 ↗ Method of use U-1995 Oct 10, 2037
US 10874648 ↗ Method of use U-3046 Oct 10, 2037
US 11311532 ↗ Method of use U-1995 Sep 18, 2038
US 11311532 ↗ Method of use U-1995 Sep 18, 2038
US 11311532 ↗ Method of use U-1995 Sep 18, 2038
US 10857137 ↗ Method of use U-1995 Oct 10, 2037
US 10857148 ↗ Method of use U-1995 Oct 10, 2037
US 10844058 ↗ Drug substance U-1995 Oct 28, 2036
US 10851103 ↗ Drug substance U-1995 Oct 28, 2036
US 10851104 ↗ Drug substance U-1995 Oct 28, 2036
US 10851104 ↗ Drug substance U-1995 Oct 28, 2036
US 10857148 ↗ Method of use U-1995 Oct 10, 2037
US 10851103 ↗ Drug substance U-1995 Oct 28, 2036
US 10857137 ↗ Method of use U-1995 Oct 10, 2037
US 10844058 ↗ Drug substance U-1995 Oct 28, 2036
US 10952997 ↗ Method of use U-1995 Oct 10, 2037
US 10940141 ↗ Method of use U-1995 Aug 10, 2040
US 10952997 ↗ Method of use U-1995 Oct 10, 2037
US 10940141 ↗ Method of use U-1995 Aug 10, 2040
US 11654142 ↗ Method of use U-3055 Nov 14, 2038
US 11654142 ↗ Method of use U-3055 Nov 14, 2038
US 11654142 ↗ Method of use U-3055 Nov 14, 2038
US 11439629 ↗ Method of use U-3055 Oct 10, 2037
US 11439629 ↗ Method of use U-3055 Oct 10, 2037
US 11439629 ↗ Method of use U-3055 Oct 10, 2037
US 11311532 ↗ Method of use U-3055 Sep 18, 2038
US 11311532 ↗ Method of use U-3055 Sep 18, 2038
US 11311532 ↗ Method of use U-3055 Sep 18, 2038
US 10065952 ↗ Drug substance U-1995 Oct 28, 2036
US 11026939 ↗ Method of use U-3055 Sep 18, 2038
US 11026939 ↗ Method of use U-3055 Sep 18, 2038
US 11026939 ↗ Method of use U-3055 Sep 18, 2038
US 10912771 ↗ Method of use U-3055 Oct 10, 2037
US 10912771 ↗ Method of use U-3055 Oct 10, 2037
US 10912771 ↗ Method of use U-3055 Oct 10, 2037
US 10874648 ↗ Method of use U-3055 Oct 10, 2037
US 10874648 ↗ Method of use U-3055 Oct 10, 2037
US 10874648 ↗ Method of use U-3055 Oct 10, 2037
US 10851104 ↗ Drug substance U-3055 Oct 28, 2036
US 10851104 ↗ Drug substance U-3055 Oct 28, 2036
US 10851104 ↗ Drug substance U-3055 Oct 28, 2036
US 10851103 ↗ Drug substance U-3055 Oct 28, 2036
US 10851103 ↗ Drug substance U-3055 Oct 28, 2036
US 10851103 ↗ Drug substance U-3055 Oct 28, 2036
US 10844058 ↗ Drug substance U-3055 Oct 28, 2036
US 10844058 ↗ Drug substance U-3055 Oct 28, 2036
US 10844058 ↗ Drug substance U-3055 Oct 28, 2036
US 10065952 ↗ Drug substance U-3055 Oct 28, 2036
US 10065952 ↗ Drug substance U-3055 Oct 28, 2036
US 10065952 ↗ Drug substance U-3055 Oct 28, 2036
US 8357697 ↗ Method of use U-3055 Nov 8, 2027
US 8357697 ↗ Method of use U-3055 Nov 8, 2027
US 8357697 ↗ Method of use U-3055 Nov 8, 2027
US 8357697 ↗ Method of use U-1995 Nov 8, 2027
US 10851104 ↗ Drug substance U-1995 Oct 28, 2036
US 10844058 ↗ Drug substance U-1995 Oct 28, 2036
US 10851103 ↗ Drug substance U-1995 Oct 28, 2036
US 10857137 ↗ Method of use U-1995 Oct 10, 2037
US 10065952 ↗ Drug substance U-1995 Oct 28, 2036
US 10857148 ↗ Method of use U-1995 Oct 10, 2037
US 10874648 ↗ Method of use U-1995 Oct 10, 2037
US 10874648 ↗ Method of use U-3046 Oct 10, 2037
US 10912771 ↗ Method of use U-3076 Oct 10, 2037
US 10912771 ↗ Method of use U-1995 Oct 10, 2037
US 10993941 ↗ Method of use U-1995 Oct 10, 2037
US 10940141 ↗ Method of use U-1995 Aug 10, 2040
US 8357697 ↗ Method of use U-1995 Nov 8, 2027
US 10952997 ↗ Method of use U-1995 Oct 10, 2037
US 10993941 ↗ Method of use U-1995 Oct 10, 2037
US 10993941 ↗ Method of use U-1995 Oct 10, 2037
US 11026931 ↗ Method of use U-1995 Aug 14, 2039
US 11026939 ↗ Method of use U-1995 Sep 18, 2038
US 11040029 ↗ Method of use U-1995 Oct 10, 2037
US 11026931 ↗ Method of use U-1995 Aug 14, 2039
US 11026939 ↗ Method of use U-1995 Sep 18, 2038
US 11040029 ↗ Method of use U-1995 Oct 10, 2037
US 11026931 ↗ Method of use U-1995 Aug 14, 2039
US 11040029 ↗ Method of use U-1995 Oct 10, 2037
US 11026939 ↗ Method of use U-1995 Sep 18, 2038
US 10912771 ↗ Method of use U-1995 Oct 10, 2037
US 10912771 ↗ Method of use U-3076 Oct 10, 2037
US 10912771 ↗ Method of use U-1995 Oct 10, 2037
US 10912771 ↗ Method of use U-3076 Oct 10, 2037
US 10906902 ↗ Drug substance — Dec 22, 2036
US 8039627 ↗ Drug substance — Apr 11, 2031
US 10919892 ↗ Drug substance — Dec 22, 2036
US 10919892 ↗ Drug substance — Dec 22, 2036
US 10906903 ↗ Drug substance — Dec 22, 2036
US 10906902 ↗ Drug substance — Dec 22, 2036
US 8039627 ↗ Drug substance — Apr 11, 2031
US 10906902 ↗ Drug substance — Dec 22, 2036
US 10906903 ↗ Drug substance — Dec 22, 2036
US 10919892 ↗ Drug substance — Dec 22, 2036
US 8039627 ↗ Drug substance — Apr 11, 2031
US 10906903 ↗ Drug substance — Dec 22, 2036
FDA exclusivity
CodeWhat it grantsExpires
I-925New indication (3-year)Aug 18, 2026
ODE-440Orphan Drug Exclusivity (7-year)Aug 18, 2030
I-925New indication (3-year)Aug 18, 2026
ODE-440Orphan Drug Exclusivity (7-year)Aug 18, 2030
I-925New indication (3-year)Aug 18, 2026
ODE-440Orphan Drug Exclusivity (7-year)Aug 18, 2030
Common questions
Is there a generic version of INGREZZA INITIATION PK(TARDIV)?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for INGREZZA INITIATION PK(TARDIV). See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70370-2048-06, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
84
Units reimbursed last 4 qtrs
2.4K
Gross reimbursed last 4 qtrs
$724.4K
Avg / prescription
$8,624.39
Avg / unit
$308.01
Latest quarter Q4 2025
31Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 84 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 392 units · 2.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,960 units · 5.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.05.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 5.0 /100k
2 New York 2.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ingrezza — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ingrezza. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$585.92M
Claims incl. refills
75K
Beneficiaries
26.9K
Spend / beneficiary
$21,792.64
Spend / claim
$7,810.45
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for INGREZZA (this brand).

Top reported reactions

Somnolence2,466
Fatigue1,679
Tremor1,580
Tardive Dyskinesia1,513
Fall1,128
Dizziness955
Death932

Age at onset

Infant1
Child4
Adolescent5
Adult2,128
Elderly1,448

Reporter sex

24,993 reports
Male · 33%
Female · 67%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,279 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70370-2048-06 You're viewing this 1 BLISTER PACK in 1 CARTON (70370-2048-6) / 1 KIT in 1 BLISTER PACK 2018-12-14 Active

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70370-2048-6, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70370-2048-06, written without dashes as 70370204806. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70370-2048-06, the first segment (70370) is the labeler code FDA assigned to Neurocrine Biosciences, Inc.; the middle segment (2048) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Neurocrine Biosciences, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Neurocrine Biosciences, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Anyone considering the use of INGREZZA or INGREZZA SPRINKLE must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior.

Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )]. WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS WITH HUNTINGTON’S DISEASE See full prescribing information for complete boxed warning. • Increases the risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease ( 5.1 ) • Balance risks of depression, and suicidal ideation and behavior with the clinical need for treatment of chorea when considering the use of INGREZZA or INGREZZA SPRINKLE ( 5.1 ) • Monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior ( 5.1 ) • Inform patients, caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician ( 5.1 ) • Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation ( 5.1 )

🎯 Indications and Usage 72 words ▾

1 INDICATIONS AND USAGE INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14.1 )] . - chorea associated with Huntington’s disease [see Clinical Studies ( 14.2 )] . INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia. ( 1 ) - chorea associated with Huntington’s disease. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Tardive dyskinesia: The initial dosage is 40 mg once daily. After one week, increase the dose to the recommended dosage of 80 mg once daily. ( 2.1 ) Chorea associated with Huntington’s disease: The initial dosage is 40 mg once daily.

Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily. ( 2.1 ) 40 mg or 60 mg once daily may be considered depending on response and tolerability. ( 2.1 ) Can be taken with or without food.

( 2.2 ) INGREZZA SPRINKLE may be opened and sprinkled over soft food (do not use milk or drinking water). INGREZZA SPRINKLE may be swallowed whole with water. Do not crush or chew.

( 2.2 ) The recommended dosage for patients with moderate or severe hepatic impairment is 40 mg once daily. ( 2.3 ) The recommended dosage for known CYP2D6 poor metabolizers is 40 mg once daily. ( 2.4 )

2.1Recommended Dosage Tardive Dyskinesia The initial dosage for INGREZZA and INGREZZA SPRINKLE is 40 mg once daily. After one week, increase the dose to the recommended dosage of 80 mg once daily. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability.

Chorea Associated with Huntington ’s Disease The initial dosage for INGREZZA and INGREZZA SPRINKLE is 40 mg once daily. Increase the dose in 20 mg increments every two weeks to the recommended dosage of 80 mg once daily. A dosage of 40 mg or 60 mg once daily may be considered depending on response and tolerability.

2.2Administrative Information Administer INGREZZA and INGREZZA SPRINKLE orally with or without food [see Clinical Pharmacology ( 12.3 )] . Administration Information for INGREZZA SPRINKLE • Open INGREZZA SPRINKLE and sprinkle the entire contents of the capsule over a bowl containing a small amount (1 tablespoonful) of soft food such as applesauce, yogurt, or pudding. Do not sprinkle the contents of the capsule into milk or drinking water.

Stir the contents of the capsule into the soft food with the tablespoon and swallow the drug/food mixture immediately. If necessary, the mixture can be stored for up to 2 hours at room temperature. Discard of any unused portion after 2 hours.

Following administration of the drug/food mixture, drink a glass (e.g., 240 mL) of water. Do not administer INGREZZA SPRINKLE via nasogastric, gastrostomy, or other enteral tubes because it may cause obstruction of enteral tubes. • INGREZZA SPRINKLE may be swallowed whole with water. Do not crush or chew INGREZZA SPRINKLE.

2. 3 Dosage Recommendations for Patients with Hepatic Impairment The recommended dosage for patients with moderate or severe hepatic impairment (Child-Pugh score 7 to 15) is INGREZZA or INGREZZA SPRINKLE 40 mg once daily [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )]. 2.

4 Dosage Recommendations for Known CYP2D6 Poor Metabolizers The recommended dosage for known CYP2D6 poor metabolizers is INGREZZA or INGREZZA SPRINKLE 40 mg once daily [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 , 12.5 )]. 2. 5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inducers and Strong CYP3A4 or CYP2D6 Inhibitors Coadministration with Strong CYP3A4 Inducers Concomitant use of strong CYP3A4 inducers with INGREZZA or INGREZZA SPRINKLE is not recommended [ see Drug Interactions ( 7.1 ) ] .

Coadministration with Strong CYP3A4 Inhibitors The recommended dosage for patients receiving strong CYP3A4 inhibitors is INGREZZA or INGREZZA SPRINKLE 40 mg once daily [see Drug Interactions ( 7.1 )]. Coadministration with Strong CYP2D6 Inhibitors The recommended dosage for patients receiving strong CYP2D6 inhibitors is INGREZZA or INGREZZA SPRINKLE 40 mg once daily [see Drug Interactions ( 7.1 )].

💊 Dosage Forms and Strengths 204 words ▾

3 DOSAGE FORMS AND STRENGTHS INGREZZA 40 mg capsule: white opaque body and purple cap, printed with ‘VBZ’ and ‘40’ in black ink. Each capsule contains 40 mg valbenazine. 60 mg capsule: dark red opaque body and purple cap, printed with ‘VBZ’ and ‘60’ in black ink.

Each capsule contains 60 mg valbenazine. 80 mg capsule: purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink. Each capsule contains 80 mg valbenazine.

INGREZZA SPRINKLE 40 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 40” in black ink on both the cap and body. Each capsule contains 40 mg valbenazine. 60 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 60” in orange to dark red ink on both the cap and body.

Each capsule contains 60 mg valbenazine. 80 mg capsule: pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 80” in purple ink on both the cap and body. Each capsule contains 80 mg valbenazine.

INGREZZA capsules: 40 mg, 60 mg and 80 mg. ( 3 ) INGREZZA SPRINKLE capsules: 40 mg, 60 mg, and 80 mg. ( 3 )

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS INGREZZA and INGREZZA SPRINKLE are contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported with use of INGREZZA [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )]. Known hypersensitivity to valbenazine or any components of INGREZZA or INGREZZA SPRINKLE.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Depression and suicidal ideation and behavior in patients with Huntington’s disease. ( 5.1 ) Hypersensitivity, including angioedema may occur. Discontinue if this occurs.

( 5.2 ) Somnolence/sedation: May impair patient’s ability to drive or operate hazardous machinery. ( 5.3 ) QT Prolongation: May cause an increase in QT interval. Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval.

( 5.4 ) Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs. ( 5.5 ) Parkinsonism: Cases of parkinson-like symptoms, some of which were severe, have been reported in the postmarketing period. Reduce the dose or discontinue INGREZZA or INGREZZA SPRINKLE treatment in patients who develop clinically significant parkinson-like signs or symptoms.

( 5.6 )

5.1Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease Patients with Huntington’s disease are at increased risk for depression, and suicidal ideation or behaviors. VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can increase the risk for suicidal ideation and behaviors in patients with Huntington’s disease. In a 14-week, double-blind, placebo-controlled trial [see Clinical Studies ( 14.2 )] , depression or depressed mood was reported in 4.7% of patients taking INGREZZA compared to 1.6% of patients who received placebo, and no patients taking INGREZZA reported suicidal ideation or behavior compared to 1 patient (1.6%) who received placebo.

Patients with significant risk for suicidal behavior or with unstable psychiatric symptoms were excluded from this trial. Suicidal ideation (9 subjects; 7.2%) and suicide attempts (3 subjects; 2.4%) were reported in the longer open-label extension trial (N=125). When considering the use of INGREZZA or INGREZZA SPRINKLE, the risk of suicidal ideation and behaviors must be balanced against the need for treatment of chorea.

All patients treated with INGREZZA and INGREZZA SPRINKLE should be observed for new or worsening depression, suicidal ideation or behaviors. If any of these reactions occur and do not resolve, consider discontinuing treatment with INGREZZA or INGREZZA SPRINKLE.

5.2Hypersensitivity Reactions Hypersensitivity reactions, including cases of angioedema involving the larynx, glottis, lips, and eyelids, have been reported in the postmarketing setting in patients after taking the first or subsequent doses of INGREZZA [see Adverse Reactions ( 6.2 )] . A case of angioedema involving the lips and face, with rash and shortness of breath was reported in a patient with Huntington’s disease taking INGREZZA during a clinical study. Urticaria and rash were also reported during a clinical study in patients with Huntington’s disease.

Angioedema associated with laryngeal edema can be fatal. If any of these reactions occur, discontinue INGREZZA or INGREZZA SPRINKLE. 5.

3 Somnolence and Sedation INGREZZA and INGREZZA SPRINKLE can cause somnolence and sedation, which was the most common adverse reaction in placebo-controlled trials with INGREZZA [see Adverse Reactions ( 6.1 )] . Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA or INGREZZA SPRINKLE . 5.

4 QT Prolongation INGREZZA and INGREZZA SPRINKLE may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. In patients taking a strong CYP2D6 or CYP3A4 inhibitor, or who are CYP2D6 poor metabolizers, INGREZZA and INGREZZA SPRINKLE concentrations may be higher and QT prolongation clinically significant [see Clinical Pharmacology ( 12.2 )] . For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary.

For patients taking a strong CYP3A4 inhibitor, reduce the dose of INGREZZA or INGREZZA SPRINKLE to…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 ) ] Somnolence and Sedation [see Warnings and Precautions ( 5.3 )] QT Prolongation [see Warnings and Precautions ( 5.4 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.5 )] Parkinsonism [see Warnings and Precautions ( 5.6 )] Most common adverse reaction (≥5% and twice the rate of placebo): - Tardive dyskinesia: somnolence.

( 6.1 ) - Chorea associated with Huntington’s disease: somnolence/lethargy/sedation, urticaria, rash, insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurocrine Biosciences, Inc. at 877-641-3461 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of INGREZZA SPRINKLE has been established from adequate and well-controlled studies of INGREZZA [see Clinical Studies ( 14 )] . Below is a display of the adverse reactions of INGREZZA in these adequate and well-controlled studies.

Tardive Dyskinesia Variable and Fixed Dose Placebo-Controlled Trial Experience The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose, dose escalation, dose reduction), including 445 patients. Patients were 26 to 84 years of age with moderate to severe tardive dyskinesia and had concurrent diagnoses of mood disorder (27%) or schizophrenia/ schizoaffective disorder (72%). The mean age was 56 years.

Patients were 57% Caucasian, 39% African-American, and 4% other. With respect to ethnicity, 28% were Hispanic or Latino. All subjects continued previous stable regimens of antipsychotics; 85% and 27% of subjects, respectively, were taking atypical and typical antipsychotic medications at study entry.

Adverse Reactions Leading to Discontinuation of Treatment A total of 3% of INGREZZA-treated patients and 2% of placebo-treated patients discontinued because of adverse reactions. Common Adverse Reactions Adverse reactions that occurred in the 3 placebo-controlled studies at an incidence of ≥2% and greater than placebo are presented in Table 1 . Table 1: Adverse Reactions in 3 Placebo-Controlled Studies of 6-week Treatment Duration Reported at ≥2% and >Placebo – Tardive Dyskinesia Adverse Reaction 1 INGREZZA (n=262) % Placebo (n=183) % General Disorders Somnolence (somnolence, fatigue, sedation) 10.9

4.2Nervous System Disorders Anticholinergic effects 5.4 4.9 (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention) Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder) 4.1

2.2Headache 3.4

2.7Akathisia (akathisia, restlessness) 2.7

0.5Gastrointestinal Disorders Vomiting 2.6

0.6Nausea 2.3

2.1Musculoskeletal Disorders Arthralgia 2.3 0.5 1 Within each adverse reaction category, the observed adverse reactions are listed in order of decreasing frequency. Other Adverse Reactions Observed During the Premarketing Evaluation of INGREZZA Other adverse reactions of ≥1% incidence and greater than placebo are shown below. The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.

Endocrine Disorders: blood glucose increased General Disorders: weight increased Infectious Dis…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Dose adjustments due to drug interactions ( 2.4 , 7.1 ): Factors Dose Adjustments for INGREZZA and INGREZZA SPRINKLE Use of MAOIs with INGREZZA or INGREZZA SPRINKLE Avoid concomitant use with MAOIs. Use of strong CYP3A4 inducers with INGREZZA or INGREZZA SPRINKLE Concomitant use is not recommended. Use of strong CYP3A4 inhibitors with INGREZZA or INGREZZA SPRINKLE Recommended dosage is 40 mg once daily.

Use of strong CYP2D6 inhibitors with INGREZZA or INGREZZA SPRINKLE Recommended dosage is 40 mg once daily.

7.1Drugs Having Clinically Important Interactions with INGREZZA and INGREZZA SPRINKLE Table 3: Clinically Significant Drug Interactions with INGREZZA and INGREZZA SPRINKLE Monoamine Oxidase Inhibitors (MAOIs) Clinical Implication: Concomitant use of INGREZZA or INGREZZA SPRINKLE with MAOIs may increase the concentration of monoamine neurotransmitters in synapses, potentially leading to increased risk of adverse reactions such as serotonin syndrome, or attenuated treatment effect of INGREZZA or INGREZZA SPRINKLE. Prevention or Management: Avoid concomitant use of INGREZZA or INGREZZA SPRINKLE with MAOIs, or within 14 days of discontinuing therapy with an MAOI.

Strong CYP3A4 Inhibitors Clinical Implication: Concomitant use of INGREZZA or INGREZZA SPRINKLE with strong CYP3A4 inhibitors increased the exposure (C max and AUC) to valbenazine and its active metabolite compared with the use of INGREZZA or INGREZZA SPRINKLE alone [see Clinical Pharmacology ( 12.3 )]. Increased exposure of valbenazine and its active metabolite may increase the risk of exposure-related adverse reactions [see Warnings and Precautions ( 5.4 )]. Prevention or Management: Reduce INGREZZA or INGREZZA SPRINKLE dose when INGREZZA or INGREZZA SPRINKLE is coadministered with a strong CYP3A4 inhibitor [see Dosage and Administration ( 2.5 )].

Strong CYP2D6 Inhibitors Clinical Implication: Concomitant use of INGREZZA or INGREZZA SPRINKLE with strong CYP2D6 inhibitors increased the exposure (C max and AUC) to valbenazine’s active metabolite compared with the use of INGREZZA or INGREZZA SPRINKLE alone [see Clinical Pharmacology ( 12.3 , 12.5 )] . Increased exposure of active metabolite may increase the risk of exposure-related adverse reactions [see Warnings and Precautions ( 5.4 )]. Prevention or Management: Reduce INGREZZA or INGREZZA SPRINKLE dose when INGREZZA or INGREZZA SPRINKLE is coadministered with a strong CYP2D6 inhibitor [see Dosage and Administration ( 2.5 )].

Strong CYP3A4 Inducers Clinical Implication: Concomitant use of INGREZZA or INGREZZA SPRINKLE with a strong CYP3A4 inducer decreased the exposure of valbenazine and its active metabolite compared to the use of INGREZZA or INGREZZA SPRINKLE alone. Reduced exposure of valbenazine and its active metabolite may reduce efficacy [see Clinical Pharmacology ( 12.3 )]. Prevention or Management: Concomitant use of strong CYP3A4 inducers with INGREZZA or INGREZZA SPRINKLE is not recommended [see Dosage and Administration ( 2.5 )].

Digoxin Clinical Implication: Concomitant use of INGREZZA or INGREZZA SPRINKLE with digoxin increased digoxin levels because of inhibition of intestinal P-glycoprotein (P-gp) [see Clinical Pharmacology ( 12.3 )] . Prevention or Management: Digoxin concentrations should be monitored when co-administering INGREZZA or INGREZZA SPRINKLE with digoxin. Increased digoxin exposure may increase the risk of exposure-related adverse reactions.

Dosage adjustment of digoxin may be necessary.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary The limited available data on INGREZZA or INGREZZA SPRINKLE use in pregnant women are insufficient to inform a drug-associated risk. In animal reproductive studies, no malformations were observed when valbenazine was administered orally to rats and rabbits during the period of organogenesis at doses up to 1.8 or 24 times, respectively, the maximum recommended human dose (MRHD) of 80 mg/day based on mg/m 2 body surface area. However, administration of valbenazine to pregnant rats during organogenesis through lactation produced an increase in the number of stillborn pups and postnatal pup mortalities at doses <1 times the MRHD based on mg/m 2 [see Data ].

Advise a pregnant woman of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

The background risk of major birth defects and miscarriage in the U.S. general population is 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively. Data Animal Data Valbenazine was administered orally to pregnant rats during the period of organogenesis at 1, 5, and 15 mg/kg/day, which are approximately 0.1, 0.6, and 2 times the MRHD of 80 mg/day based on mg/m 2 body surface area. Valbenazine produced a significant decrease in maternal body weight gain at 0.6 and 2 times the MRHD of 80 mg/day based on mg/m 2 .

No adverse embryo fetal effects were produced when valbenazine was administered at doses up to 2 times the MRHD of 80 mg/day based on mg/m 2 . Valbenazine was administered orally to pregnant rabbits during the period of organogenesis at 20, 50, and 100 mg/kg/day, which are approximately 5, 12, and 24 times the MRHD of 80 mg/day based on mg/m 2 . No malformations were observed at doses up to 24 times the MRHD of 80 mg/day based on mg/m 2 .

However, valbenazine produced a delay in fetal development (decreased fetal weights and delayed ossification) at 24 times the MRHD of 80 mg/day based on mg/m 2 , likely secondary to maternal toxicity (decreased food intake and loss in body weight). Valbenazine was administered orally to pregnant rats during the period of organogenesis through lactation (day 7 of gestation through day 20 postpartum) at 1, 3, and 10 mg/kg/day, which are approximately 0.1, 0.4, and 1.2 times the MRHD of 80 mg/day based on mg/m 2 . Valbenazine produced an increase in the incidence of stillbirths and postnatal pup mortality at 0.4 and 1.2 times the MRHD of 80 mg/day based on mg/m 2 .

Valbenazine did not affect neurobehavioral function including learning and memory and had no effect on sexual maturation at doses <1 times the MRHD of 80 mg/day based on mg/m 2 (because of death in the majority of the high dose group (1.2 times the MRHD), these parameters were not assessed in this group).

8.2Lactation Risk Summary There is no information regarding the presence of valbenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Valbenazine and its metabolites have been detected in rat milk at concentrations higher than in plasma following oral administration of valbenazine at doses 0.1 to 1.2 times the MRHD based on mg/m 2 . Based on animal findings of increased perinatal mortality in exposed fetuses and pups, advise a woman not to breastfeed during treatment with INGREZZA or INGREZZA SPRINKLE and for 5 days after the final dose.

8.4Pediatric Use Safety and effectiveness of INGREZZA and INGREZZA SPRINKLE have not been established in pediatric patients.

8.5Geriatric Use No dose adjustment of INGREZZA or INGREZZA SPRINKLE is required for elderly patients. Tardive Dyskinesia In 3 randomized, placebo-controlled studies of INGREZZA in patients with tardive dyskinesia, 16% of patients were 65 years and ol…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The limited available data on INGREZZA or INGREZZA SPRINKLE use in pregnant women are insufficient to inform a drug-associated risk. In animal reproductive studies, no malformations were observed when valbenazine was administered orally to rats and rabbits during the period of organogenesis at doses up to 1.8 or 24 times, respectively, the maximum recommended human dose (MRHD) of 80 mg/day based on mg/m 2 body surface area. However, administration of valbenazine to pregnant rats during organogenesis through lactation produced an increase in the number of stillborn pups and postnatal pup mortalities at doses <1 times the MRHD based on mg/m 2 [see Data ].

Advise a pregnant woman of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

The background risk of major birth defects and miscarriage in the U.S. general population is 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively. Data Animal Data Valbenazine was administered orally to pregnant rats during the period of organogenesis at 1, 5, and 15 mg/kg/day, which are approximately 0.1, 0.6, and 2 times the MRHD of 80 mg/day based on mg/m 2 body surface area. Valbenazine produced a significant decrease in maternal body weight gain at 0.6 and 2 times the MRHD of 80 mg/day based on mg/m 2 .

No adverse embryo fetal effects were produced when valbenazine was administered at doses up to 2 times the MRHD of 80 mg/day based on mg/m 2 . Valbenazine was administered orally to pregnant rabbits during the period of organogenesis at 20, 50, and 100 mg/kg/day, which are approximately 5, 12, and 24 times the MRHD of 80 mg/day based on mg/m 2 . No malformations were observed at doses up to 24 times the MRHD of 80 mg/day based on mg/m 2 .

However, valbenazine produced a delay in fetal development (decreased fetal weights and delayed ossification) at 24 times the MRHD of 80 mg/day based on mg/m 2 , likely secondary to maternal toxicity (decreased food intake and loss in body weight). Valbenazine was administered orally to pregnant rats during the period of organogenesis through lactation (day 7 of gestation through day 20 postpartum) at 1, 3, and 10 mg/kg/day, which are approximately 0.1, 0.4, and 1.2 times the MRHD of 80 mg/day based on mg/m 2 . Valbenazine produced an increase in the incidence of stillbirths and postnatal pup mortality at 0.4 and 1.2 times the MRHD of 80 mg/day based on mg/m 2 .

Valbenazine did not affect neurobehavioral function including learning and memory and had no effect on sexual maturation at doses <1 times the MRHD of 80 mg/day based on mg/m 2 (because of death in the majority of the high dose group (1.2 times the MRHD), these parameters were not assessed in this group).

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness of INGREZZA and INGREZZA SPRINKLE have not been established in pediatric patients.

🧓 Geriatric Use 107 words ▾

8.5Geriatric Use No dose adjustment of INGREZZA or INGREZZA SPRINKLE is required for elderly patients. Tardive Dyskinesia In 3 randomized, placebo-controlled studies of INGREZZA in patients with tardive dyskinesia, 16% of patients were 65 years and older. The safety and effectiveness were similar in patients older than 65 years compared to younger patients.

Huntington’s Disease In the randomized, placebo-controlled study of INGREZZA in 127 patients with chorea associated with Huntington’s disease, 15% were 65 years and older. This study did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently from younger subjects [see Clinical Studies ( 14.2 )] .

🆘 Overdosage 71 words ▾

10 OVERDOSAGE Human Experience The pre-marketing clinical trials involving INGREZZA in approximately 850 subjects do not provide information regarding symptoms with overdose. Management of Overdosage No specific antidotes for INGREZZA or INGREZZA SPRINKLE are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY Figure 1 Figure 2 Figure 3

12.1Mechanism of Action The mechanism of action of valbenazine for the treatment of tardive dyskinesia and chorea in patients with Huntington’s disease is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.

12.2Pharmacodynamics Valbenazine inhibits human VMAT2 (Ki ~ 150 nM) with no appreciable binding affinity for VMAT1 (Ki > 10 µM). Valbenazine is converted to the active metabolite [+]-α-dihydrotetrabenazine ([+]-α-HTBZ). [+]-α-HTBZ also binds with relatively high affinity to human VMAT2 (Ki ~ 3 nM). Valbenazine and [+]-α-HTBZ have no appreciable binding affinity (Ki > 5000 nM) for dopaminergic (including D2), serotonergic (including 5HT2B), adrenergic, histaminergic or muscarinic receptors.

Cardiac Electrophysiology INGREZZA and INGREZZA SPRINKLE may cause an increase in the corrected QT interval in patients who are CYP2D6 poor metabolizers or who are taking a strong CYP2D6 or CYP3A4 inhibitor. An exposure-response analysis of clinical data from two healthy volunteer studies revealed increased QTc interval with higher plasma concentrations of the active metabolite. Based on this model, patients taking an INGREZZA 60 mg or 80 mg dose with increased exposure to the metabolite (e.g., being a CYP2D6 poor metabolizer) may have a mean (upper bound of double-sided 90% CI) QT prolongation of 9.6 (12.0) msec or 11.7 (14.7) msec, respectively as compared to otherwise healthy volunteers given INGREZZA, who had a respective mean (upper bound of double-sided 90% CI) QT prolongation of 5.3 (6.7) msec or 6.7 (8.4) msec [see Warnings and Precautions ( 5.4 )] .

12.3Pharmacokinetics Valbenazine and its active metabolite ([+]-α-HTBZ) demonstrate approximate proportional increases for the area under the plasma concentration versus time curve (AUC) and maximum plasma concentration (C max ) after single oral doses from 40 mg to 300 mg (i.e., 50% to 375% of the recommended treatment dose). Absorption INGREZZA Following oral administration of INGREZZA, the time to reach maximum valbenazine plasma concentration (t max ) ranges from 0.5 to 1.0 hours. Valbenazine reaches steady state plasma concentrations within 1 week.

The absolute oral bioavailability of valbenazine is approximately 49%. [+]-α-HTBZ gradually forms and reaches C max 4 to 8 hours after administration of INGREZZA. INGREZZA SPRINKLE Following administration of 80 mg INGREZZA SPRINKLE orally as sprinkle on applesauce, the geometric mean peak plasma concentration (C max ) of valbenazine was 512 ng/mL, area under the plasma concentration-time curve (AUC inf ) was 5,600 ng*hr/mL and the median time to reach C max (T max ) was 1.5 hours. For the [+]-α-HTBZ metabolite, the geometric mean C max was 23 ng/mL, AUC inf was 739 ng*hr/mL and the median T max was 6 hours.

Following oral administration of 80 mg INGREZZA, the geometric mean C max , AUC inf and median T max of valbenazine were 744 ng/mL, 6,419 ng*hr/mL and 0.5 hour, respectively. For the [+]-α-HTBZ metabolite, the geometric mean C max was 26 ng/mL, AUC inf was 859 ng*hr/mL and the median T max was 6 hours. When 80 mg INGREZZA SPRINKLE capsules were swallowed whole with water, the geometric mean valbenazine C max , AUC inf and median T max were 685 ng/mL, 5,981 ng*hr/mL and 1 hour, respectively.

For the [+]-α-HTBZ metabolite, the geometric mean C max was 23 ng/mL, AUC inf was 772 ng*hr/mL and the median T max was 6 hours. Effect of Food INGREZZA Ingestion of a high-fat meal decreases valbenazine C max by approximately 47% and AUC by approximately 13%. [+]-α-HTBZ C max and AUC are unaffected. INGREZZA SPRINKLE Ingestion of a high-fat meal decreases valbenazine C max by approximately 15% and did not have an appreciable effect on AUC. [+]-α-HTBZ C max and AUC are unaffected.

Distribution The plasma protein b…

🧬 Mechanism of Action 58 words ▾

12.1Mechanism of Action The mechanism of action of valbenazine for the treatment of tardive dyskinesia and chorea in patients with Huntington’s disease is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied INGREZZA (valbenazine) capsules are available as: 40 mg Capsule: White opaque body with a purple cap, printed with ‘VBZ’ and ‘40’ in black ink. 60 mg Capsule: Dark red opaque body with a purple cap, printed with ‘VBZ’ and ‘60’ in black ink. 80 mg Capsule: Purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink.

INGREZZA SPRINKLE (valbenazine) capsules are available as: 40 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 40” in black ink on both the cap and body. 60 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 60” in orange to dark red ink on both the cap and body. 80 mg Capsule: Pearl white opaque cap and body, printed with a band, directional arrows, and “VBZ 80” in purple ink on both the cap and body.

Table 6: INGREZZA and INGREZZA SPRINKLE Configurations and NDC Numbers Package Configuration Capsule Strength NDC Number INGREZZA Bottle of 30 40 mg NDC 70370-2040-1 Bottle of 30 60 mg NDC 70370-1060-1 Bottle of 30 80 mg NDC 70370-1080-1 4-week Initiation Pack for tardive dyskinesia 28-day blister pack containing: 7 x 40 mg and 21 x 80 mg NDC 70370-2048-6 4-week Initiation Pack for chorea associated with Huntington’s disease 28-day blister pack containing: 14 x 40 mg and 14 x 60 mg NDC 70370-2046-1 INGREZZA SPRINKLE Bottle of 30 40 mg NDC 70370-4040-1 Bottle of 30 60 mg NDC 70370-4060-1 Bottle of 30 80 mg NDC 70370-4080-1 Storage INGREZZA: Store at 15°C to 30°C (59°F to 86°F).

INGREZZA SPRINKLE: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.

Dispense in original container or in a tight container as defined in USP.

📋 Description ~1 min read ▾

11 DESCRIPTION INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, ( 2R,3R ,11b R )-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2 H -benzo[ a ]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C 38 H 54 N 2 O 10 S 2 , and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure: The molecular formula of valbenazine free base is C 24 H 38 N 2 O 4 and its molecular weight is 418.57.

INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose.

The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively.

The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine). INGREZZA contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2).

Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure:

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Depression and Suicidal Ideation and Behavior in Patients with Huntington’s Disease Inform patients, their caregivers, and families of the risks of depression, worsening depression, and suicidal ideation and behavior associated with INGREZZA and INGREZZA SPRINKLE, and instruct them to report behaviors of concern promptly to the treating physician. Patients with Huntington’s disease who express suicidal ideation should be evaluated immediately [see Warnings and Precautions ( 5.1 )] .

Hypersensitivity Reactions Inform patients about the signs and symptoms of hypersensitivity reactions, such as angioedema, including difficulty breathing, swelling of the face, lips, eyelids, tongue or throat. Advise patients to discontinue INGREZZA or INGREZZA SPRINKLE immediately if any of these reactions occur and report to the emergency room if symptoms of angioedema occur [see Warnings and Precautions ( 5.2 )] . Somnolence and Sedation Inform patients that INGREZZA and INGREZZA SPRINKLE may cause somnolence and may impair the ability to perform tasks that require complex motor and mental skills.

Advise patients that until they learn how they respond to INGREZZA or INGREZZA SPRINKLE, they should be careful or avoid doing activities that require them to be alert, such as driving a car or operating machinery [see Warnings and Precautions ( 5.3 )] . Prolongation of the QT Interval Inform patients to consult their physician immediately if they feel faint, lose consciousness, or have heart palpitations [see Warnings and Precautions ( 5.4 )] . Advise patients to inform physicians that they are taking INGREZZA or INGREZZA SPRINKLE before any new drug is taken.

Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal adverse reaction – neuroleptic malignant syndrome (NMS) – that has been reported in association with administration of VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE. Advise patients to contact a healthcare provider or report to the emergency room if they experience signs or symptoms of NMS [ see Warnings and Precautions ( 5.5 ) ] . Parkinsonism Inform patients that parkinson-like symptoms may occur while taking INGREZZA or INGREZZA SPRINKLE.

Advise patients to consult their healthcare provider if they experience difficulty moving or loss of ability to move muscles voluntarily, tremor, gait disturbances, or drooling [see Warnings and Precautions ( 5.6 )] . Pregnancy Advise a pregnant patient of the potential risk to a fetus [see Use in Specific Populations ( 8.1 )] . Lactation Advise a woman not to breastfeed during treatment with INGREZZA or INGREZZA SPRINKLE and for 5 days after the final dose [see Use in Specific Populations ( 8.2 )] .

Administration Information for INGREZZA SPRINKLE Advise patients to read and follow the Instructions for Use for INGREZZA SPRINKLE. Advise the patient of the following: INGREZZA SPRINKLE may be opened and the entire contents of the capsule sprinkled over a bowl containing a small amount (1 tablespoonful) of soft food such as applesauce, yogurt, or pudding. Stir the contents of the capsule into the soft food. ○ Do not sprinkle the contents of the capsule into milk or drinking water. ○ Swallow the drug/food mixture immediately. ○ The mixture may be stored for up to 2 hours at room temperature.

Discard any unused portion after 2 hours. ○ Drink a glass (e.g., 240 mL) of water following administration of the drug/food mixture [see Dosage and Administration ( 2.2 )] . INGREZZA SPRINKLE may also be swallowed whole with water [see Dosage and Administration ( 2.2 )] . Do not crush or chew INGREZZA SPRINKLE.

For further information on INGREZZA or INGREZZA SPRINKLE, call 84-INGREZZA (844-647-3992). Distributed by: Neurocrine Biosciences, Inc. 6027 Edgewood Bend Court San Diego, CA 92130 INGREZZA is a registered trademark of Neurocrine Bioscie…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE INGREZZA® (in greh' zah) (valbenazine) capsules INGREZZA® SPRINKLE (in greh' zah spring kuhl) (valbenazine) capsules What is the most important information I should know about INGREZZA or INGREZZA SPRINKLE ? INGREZZA or INGREZZA SPRINKLE can cause serious side effects in people with Huntington’s disease, including: ◦ depression ◦ suicidal thoughts ◦ suicidal actions Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts.

Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you: feel sad or have crying spells lose interest in seeing your friends or doing things you used to enjoy sleep a lot more or a lot less than usual feel unimportant feel guilty feel hopeless or helpless feel more irritable, angry or aggressive than usual feel more or less hungry than usual or notice a big change in your body weight have trouble paying attention feel tired or sleepy all the time have thoughts about hurting yourself or ending your life What is INGREZZA or INGREZZA SPRINKLE ?

INGREZZA or INGREZZA SPRINKLE is a prescription medicine used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). the involuntary movements (chorea) of Huntington’s disease. INGREZZA or INGREZZA SPRINKLE does not cure the cause of the involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children.

Who should not take INGREZZA or INGREZZA SPRINKLE? Do not take INGREZZA or INGREZZA SPRINKLE if you are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. See the end of this Medication Guide for a complete list of ingredients in INGREZZA or INGREZZA SPRINKLE.

Before taking INGREZZA or INGREZZA SPRINKLE , tell your healthcare provider about all of your medical conditions , including if you: have emotional or mental problems (for example, depression, nervousness, anxiety, anger, agitation, psychosis, previous suicidal thoughts or suicide attempts) have liver problems have heart disease that is not stable, have heart failure or recently had a heart attack have an irregular heart rhythm or heartbeat (QT prolongation, heart arrhythmia) are pregnant or plan to become pregnant.

INGREZZA or INGREZZA SPRINKLE may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if INGREZZA or INGREZZA SPRINKLE passes into your breast milk. Do not breastfeed during treatment with INGREZZA or INGREZZA SPRINKLE and for 5 days after the final dose.

Talk to your healthcare provider about the best way to feed your baby during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE.

Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects and may affect the way that INGREZZA or INGREZZA SPRINKLE works. Especially tell your healthcare provider if you: take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days.

Ask your healthcare provider if you are not sure if you take a MAOI. take digoxin Do not start any new medicines duri…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70370-2046-01 · Neurocrine 70370-4040-01 · Neurocrine →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.