Tetrabenazine Tablet
Product Images NDC 69452-118

5 FDA label images from Bionpharma Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Tetrabenazine (NDC 69452-118). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bionpharma 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

Figure 1 (Spl Tetrabenazine Figure 001)

Figure 1 (Spl Tetrabenazine Figure 001)
A line graph comparing the mean change from baseline in total chorea score over 14 weeks in 84 Huntington's disease patients treated with tetrabenazine (n=54) versus placebo (n=30). The x-axis represents study weeks from -1 to 14, and the y-axis shows chorea score change from 1 to -7. Two lines are shown: a solid line for tetrabenazine and a dashed line for placebo, with error bars indicating standard error of the mean (s.e.m.). The chart includes annotations for statistically significant differences (p<0.05) and a labeled washout period at week 13.*
FDA Label Image

Figure 2 (Spl Tetrabenazine Figure 002)

Figure 2 (Spl Tetrabenazine Figure 002)
A line graph depicting the cumulative percentage of patients with specified changes from baseline in total chorea score, comparing Tetrabenazine and placebo groups. The x-axis represents change from baseline in chorea score, and the y-axis shows cumulative percentage of patients. The graph includes vertical lines marking 10, 6, and 3 points improvement with corresponding data showing higher response rates for Tetrabenazine compared to placebo.*
FDA Label Image

Structural Formula (Spl Tetrabenazine Structure Formula)

Structural Formula (Spl Tetrabenazine Structure Formula)
Chemical structure of tetrabenazine. The diagram shows the molecular framework of tetrabenazine, including aromatic rings, methoxy groups, nitrogen, oxygen atoms, and hydrocarbon side chains, consistent with the compound's established chemical formula.*
FDA Label Image

12.5 mg Container Label (Tetraimage001v1)

12.5 mg Container Label (Tetraimage001v1)
Tetrabenazine Tablets 12.5 mg oral tablets label from Bionpharma Inc. The label states the product name, strength, and dose form, highlighting a 12.5 mg strength. It includes medication handling instructions, storage conditions, and cautions, plus the package contains 112 tablets. The label also features distributor and manufacturer information, barcode, NDC number 69452-117-21, and details for tracking such as GTIN, serial number, expiration, and lot number.*
FDA Label Image

25 mg Container Label (Tetraimage002v1)

25 mg Container Label (Tetraimage002v1)
Tetrabenazine Tablets 25 mg label from Bionpharma Inc. The label shows the product name, strength (25 mg), dosage form (tablets), and package count of 112 tablets. It includes storage instructions, a pharmacist dispensing note, NDC 69452-118-21, and manufacturer information (Natco Pharma Limited). The label has a barcode and various regulatory details.*

* 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.