Addyi Tablet, Film Coated
Product Images NDC 58604-214

7 FDA label images from Sprout Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Addyi (NDC 58604-214). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sprout Pharmaceuticals, 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

Addycarton New

Addycarton New
The image shows the packaging label for ADDYI (flibanserin) tablets 100 mg by Sprout Pharmaceuticals, Inc. It is an oral, film-coated tablet with 30 tablets per package. The label includes dosage instructions to take 100 mg once daily at bedtime, storage information, a barcode, and a pharmacist attention note specifying dispensing in original packaging with an enclosed Medication Guide.*
FDA Label Image

Addyibottle New

Addyibottle New
ADDYI (flibanserin) 100 mg film-coated tablets in a 30-tablet package. The label includes dosage instructions of 100 mg once daily at bedtime, storage conditions at 25°C (77°F), and a warning to keep out of reach of children. Manufactured by Sprout Pharmaceuticals, Inc. The label displays the NDC 58604-214-30 and includes a barcode on the left side.*
FDA Label Image

Addyibottle

Addyibottle
Packaging label for ADDYI (flibanserin) tablets 100 mg, film-coated oral tablets supplied in a 30-count package. The label includes the NDC 58604-214-30 and manufacturer's information from Sprout Pharmaceuticals, Inc. Dosage instructions note 100 mg once daily at bedtime with storage at 25°C (77°F). The label also instructs pharmacists to dispense the accompanying Medication Guide and indicates a non-varnish lot and expiry area.*
FDA Label Image

Addyicarton.jpg (Addyicarton)

Addyicarton.jpg (Addyicarton)
Packaging label for ADDYI (flibanserin) tablets, 100 mg, oral film-coated tablets. The label indicates the product is manufactured by Sprout Pharmaceuticals, Inc., Raleigh, NC, and includes directions for dosage and storage. The package contains 30 tablets and features the NDC code 58604-214-30, with a barcode on one side.*
FDA Label Image
Addyilogo
ADDYI (flibanserin) 100 mg film-coated tablets carton. The label shows the brand name ADDYI with the generic name flibanserin below it, and indicates a package of 100 mg tablets. The labeler is Sprout Pharmaceuticals, Inc.*
FDA Label Image

Figure 1 (Figure1)

Figure 1 (Figure1)
A line graph showing the mean and standard deviation of plasma flibanserin concentration (ng/mL) over time (hours) in healthy female subjects after a single oral dose of 100 mg flibanserin. Concentration peaks within the first hour and declines gradually over 24 hours on a linear scale.*
FDA Label Image

Structural Formula (Structuralformula)

Structural Formula (Structuralformula)
Chemical structure of flibanserin, the active ingredient in ADDYI. The structure shows fused aromatic and heterocyclic rings, including a trifluoromethyl-substituted phenyl group, a piperazine ring, and an indole moiety with a carbonyl group and an amine.*

* 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.