Ingrezza Sprinkle Capsule
Product Images NDC 70370-4060

10 FDA label images from Neurocrine Biosciences, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Ingrezza Sprinkle (NDC 70370-4060). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Neurocrine Biosciences, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

The Following Chemical Structure Of Ingrezza Contains Valbenazine, A Selective Vesicular Monoamine Transporter 2 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). (Valbenazine 01)

The Following Chemical Structure Of Ingrezza Contains Valbenazine, A Selective Vesicular Monoamine Transporter 2 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). (Valbenazine 01)
Chemical structure of valbenazine, the active ingredient in INGREZZA. The diagram shows the molecular framework with labeled carbon positions and sulfate counterions (2TsOH).*
FDA Label Image

Figure 1: Effects Of Hepatic Impairment On Valbenazine Pharmacokinetics (Valbenazine 02)

Figure 1:	Effects Of Hepatic Impairment On Valbenazine Pharmacokinetics (Valbenazine 02)
This is a fold change and 90% confidence interval plot showing the impact of hepatic and renal impairment on the pharmacokinetics of Valbenazine and its metabolite [+]-α-HTBZ. The graph displays fold changes in Cmax and AUCinf comparing mild, moderate, and severe hepatic impairment and severe renal impairment relative to reference subjects.*
FDA Label Image

Figure 2: Effects Of Strong Cyp3a4 Inducers And Inhibitors On Valbenazine Pharmacokinetics (Valbenazine 03)

Figure 2:	Effects Of Strong Cyp3a4 Inducers And Inhibitors On Valbenazine Pharmacokinetics (Valbenazine 03)
A chart illustrating fold change and 90% confidence intervals for valbenazine and its metabolite (+)-alpha-HTBZ under the influence of strong CYP2D6 inhibitor Paroxetine, strong CYP3A4 inducer Rifampin, and strong CYP3A4 inhibitor Ketoconazole. The x-axis represents change relative to reference (without interacting drug), ranging from 0.25 to 2.*
FDA Label Image

Figure 3: Effects Of Valbenazine On Pharmacokinetics Of Other Drugs (Valbenazine 04)

Figure 3:	Effects Of Valbenazine On Pharmacokinetics Of Other Drugs (Valbenazine 04)
A horizontal line plot illustrating fold change and 90% confidence intervals for the pharmacokinetics of two substrates: CYP3A4 substrate Midazolam and P-gp substrate Digoxin. The x-axis shows change relative to reference from 0.5 to 4, while the y-axis lists Cmax and AUCinf parameters for each substrate, with data points and error bars reflecting the confidence intervals of these changes.*
FDA Label Image

Figure 4: Percent Of Patients With Specified Magnitude Of Aims Total Score Improvement At The End Of Week 6 (Valbenazine 05)

Figure 4:	Percent Of Patients With Specified Magnitude Of Aims Total Score Improvement At The End Of Week 6 (Valbenazine 05)
A bar chart depicting the magnitude of improvement from baseline in AIMS Dyskinesia Total Score across patient groups treated with placebo, INGREZZA 40 mg, and INGREZZA 80 mg. The X-axis categorizes improvement levels from Missing to 10 to 13, while the Y-axis shows the percent of patients for each category. The chart compares percentages for placebo (white bars), INGREZZA 40 mg (gray bars), and INGREZZA 80 mg (black bars) groups, illustrating differences in patient outcomes.*
FDA Label Image

Figure 5: Aims Dyskinesia Total Score Mean Change From Baseline – Entire Study Duration (arithmetic Mean) (Valbenazine 06)

Figure 5:	Aims Dyskinesia Total Score Mean Change From Baseline – Entire Study Duration (arithmetic Mean) (Valbenazine 06)
A line graph depicting change from baseline in AIMS Dyskinesia Total Score over time in weeks for various treatment groups: Placebo, INGREZZA 40 mg, INGREZZA 80 mg, and respective placebo-INGREZZA crossover groups. The x-axis shows time points from 0 to 52 weeks, divided into DB Phase, INGREZZA Extension Period, and Off Drug phases. The y-axis shows the change in score, ranging from 0 to -6. Patient numbers for each group are listed below the graph for corresponding time points.*
FDA Label Image

Ndc 70370-1040-1ingrezza(valbenazine) Capsules40 mg30 Capsulesrx Only (Valbenazine 07)

Ndc 70370-1040-1ingrezza(valbenazine) Capsules40 mg30 Capsulesrx Only (Valbenazine 07)
Label for INGREZZA 40 mg capsules containing valbenazine, with 30 capsules per package. The label includes storage instructions, a barcode, and distributor information for Neurocrine Biosciences, Inc., San Diego, CA. It is marked Rx only and states to keep out of reach of children.*
FDA Label Image

Ndc 70370-1080-1ingrezza(valbenazine) Capsules80 mg30 Capsulesrx Only (Valbenazine 08)

Ndc 70370-1080-1ingrezza(valbenazine) Capsules80 mg30 Capsulesrx Only (Valbenazine 08)
INGREZZA 60 mg capsules label showing a 30-capsule bottle. The label displays the proprietary name INGREZZA and generic name valbenazine, with dosage strength of 60 mg. The label includes storage instructions and distributor information for Neurocrine Biosciences, Inc., San Diego, CA.*
FDA Label Image

Valbenazine 09

Valbenazine 09
INGREZZA 80 mg capsules label showing a 30-capsule carton with active ingredient valbenazine indicated. The label includes storage instructions, distributor information for Neurocrine Biosciences, Inc., and a warning to keep out of reach of children. The dosage form is oral capsules.*
FDA Label Image

Valbenazine 0a

Valbenazine 0a
INGREZZA (valbenazine) capsules 40 mg and 80 mg oral capsules packaging label for a 4-week (28-day) initiation pack. The label displays dosage guidance for Week 1 (40 mg capsule daily) and Weeks 2-4 (80 mg capsule daily). The box includes instructions for opening and closing and is labeled by Neurocrine Biosciences, Inc. The label also includes the NDC code 70370-2048-6 and website information www.ingrezza.com.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.