Ogsiveo Tablet, Film Coated
Product Images NDC 82448-100

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Ogsiveo (NDC 82448-100). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Springworks Therapeutics, 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 Structural Formula For Nirogacestat Hydrobromide Is: Ogsiveo Oral Tablets Contain Nirogacestat (as Nirogacestat Hydrobromide), A Gamma (ɣ) Secretase Inhibitor. Nirogacestat Hydrobromide Is Chemically Known As (s)-2-(((s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl) Pentanamide Dihydrobromide. The Empirical Formula Is C27h43br2f2n5o And The Molecular Weight Is 651.48 G/mol. Nirogacestat Hydrobromide Is A White To Off White Powder With An Aqueous Solubility Of 11.4 mg/ml And A Ph Of 4.4 In Water At 25c. Nirogacestat Dihydrobromide Is Highly Soluble At Low Ph, However The Solubility Significantly Decreases At Ph > 6.0. The Molecule Has Pka’s Of 5.77 And 7.13. (Nirogacestat 01)

Chemical structure of nirogacestat. The diagram shows the molecular structure with labeled atoms and bonds, including fluorine atoms and nitrogen functional groups, consistent with the active ingredient nirogacestat provided by SpringWorks Therapeutics, Inc.*

FDA Label Image

Figure 1 (Nirogacestat 02)

A Kaplan-Meier survival curve chart comparing progression-free survival probability over time in months for participants treated with Nirogacestat versus placebo. The chart shows two stepwise survival curves, with Nirogacestat having higher survival probabilities over the time period displayed. The number of participants at risk for both groups is indicated below the x-axis for various time points up to 32 months.*

FDA Label Image

Principal Display Panelndc 82448-050-18rx Onlyogsiveo50 mg180 Tablets (Nirogacestat 03)

Label for Ogsiveo (nirogacestat tablets) 50 mg oral film-coated tablets, manufactured by SpringWorks Therapeutics, Inc. The label indicates a bottle containing 180 tablets, with recommended storage between 20°C - 25°C and excursions permitted between 15°C - 30°C. It includes the NDC 82448-050-18 and notes the product is made in China.*

FDA Label Image

Principal Display Panelndc 82448-050-18rx Onlyogsiveo50 mg180 Tablets (Nirogacestat 04)

Ogsiveo 50 mg (nirogacestat tablets) oral tablet packaging label by SpringWorks Therapeutics, Inc. The label indicates 180 tablets per package. It includes storage instructions, dosage reference, and manufacturer contact details. The product is labeled Rx only with NDC 82448-050-18.*

FDA Label Image

Principal Display Panelndc 82448-050-18rx Onlyogsiveo50 mg180 Tablets (Nirogacestat 05)

Label for OGSIVEO nirogacestat tablets, film-coated, 50 mg strength. The label indicates 180 tablets per container, for oral use. Manufactured by SpringWorks Therapeutics, Inc. Storage instructions specify 20°C to 25°C with permissible excursions. Includes barcode, NDC number 82448-050-18, and sections for lot and expiration dates.*

FDA Label Image

Principal Display Panelndc 82448-050-18rx Onlyogsiveo50 mg180 Tablets (Nirogacestat 06)

Packaging label for Ogsiveo 50 mg film-coated tablets containing nirogacestat. The label shows a box containing 180 tablets, marked Rx only, with storage instructions and manufacturer information for SpringWorks Therapeutics, Inc. The label includes the NDC 82448-050-18 and features the product and company logos.*

* 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.