FRUZAQLA Capsule Ref.[107236] Active ingredients: Fruquintinib

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

Fruquintinib is a kinase inhibitor with the chemical name 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]-N,2-dimethyl-1-benzofuran-3-carboxamide. Its molecular formula is C21H19N3O5, which corresponds to a molecular weight of 393.39 g/mol.

Fruquintinib has the following chemical structure:

Fruquintinib is a white to off-white powder with a dissociation constant (pKa) of 2.78. The aqueous solubility of fruquintinib is pH-dependent with a solubility of 0.9 μg/mL at pH 6.8 that increases under acidic conditions to 129.9 μg/mL at pH 1.

FRUZAQLA (fruquintinib) capsules for oral administration contain 1 mg or 5 mg of fruquintinib. The inactive ingredients are corn starch, microcrystalline cellulose, and talc. The 1 mg capsule shell contains FD&C Yellow No. 5 (tartrazine), FD&C Yellow No. 6 (sunset yellow FCF), gelatin, and titanium dioxide. The 5 mg capsule shell contains FD&C Blue No. 1 (brilliant blue FCF), FD&C Red No. 40 (allura red AC), gelatin, and titanium dioxide. The printing ink for 1 mg and 5 mg capsules contains butanol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.

Dosage Forms and Strengths

Capsules:

  • 1 mg: size 3 hard gelatin capsule with standard yellow opaque cap and white opaque body, imprinted with “HM013” over “1 mg” on the body in black ink.
  • 5 mg: size 1 hard gelatin capsule with a red opaque cap and white opaque body, imprinted with “HM013” over “5 mg” on the body in black ink.
How Supplied
Capsule Strength Description Package Configuration NDC Number
1 mg Size 3 hard gelatin capsule with yellow opaque cap and white opaque body, imprinted with “HM013” over “1 mg” on the body in black ink White high-density polyethylene (HDPE) bottle with child-resistant closure packaged in a carton.
Each bottle contains 21 capsules.
63020-210-21
5 mg Size 1 hard gelatin capsule with a red opaque cap and white opaque body, imprinted with “HM013” over “5 mg” on the body in black ink 63020-225-21

Distributed by: Takeda Pharmaceuticals America, Inc., Lexington, MA 02421

Drugs

Drug Countries
FRUZAQLA United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.