ORSERDU Film-coated tablet Ref.[51290] Active ingredients: Elacestrant

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

Product description

Elacestrant dihydrochloride, the active ingredient, is an estrogen receptor antagonist, and has the chemical name: (6R)6(2-(N-(4-(2-(ethylamino)ethyl)benzyl)-N-ethylamino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol dihydrochloride. The elacestrant dihydrochloride molecular formula is C30H40Cl2N2O2 and the relative molecular mass is 531.56 g/mol. The chemical structure of elacestrant dihydrochloride is shown below:

Elacestrant dihydrochloride is a white to off-white to grey solid and is freely soluble in 0.01N HCI.

ORSERDU (elacestrant) 345 mg film-coated tablet contains 400 mg of elacestrant dihydrochloride (approximately 345 mg of elacestrant free base).

ORSERDU (elacestrant) 86 mg film-coated tablet contains 100 mg of elacestrant dihydrochloride (approximately 86 mg of elacestrant free base).

Both tablet strengths contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate (non-bovine), microcrystalline cellulose, and silicified microcrystalline cellulose. The tablets also contain Opadry II Blue (polyvinyl alcohol, titanium dioxide, polyethylene glycol, FD&C Blue #1 and talc).

Dosage Forms and Strengths

Tablets: Elacestrant 345 mg (equivalent to 400 mg elacestrant dihydrochloride) and 86 mg (equivalent to 100 mg elacestrant dihydrochloride):

  • 345 mg: light blue, unscored, oval film-coated biconvex tablet, imprinted with “MH” on one side and plain on the other side.
  • 86 mg: light blue, unscored, round film-coated biconvex tablet, imprinted with “ME” on one side and plain on the other side.
How Supplied

ORSERDU (elacestrant) film-coated tablets for oral use are supplied as follows:

Tablet Strength Tablet Color and Shape Tablet Markings Pack Size NDC Code
Elacestrant 345 mg (equivalent to 400 mg elacestrant dihydrochloride) Light blue;
Oval 		“MH” Bottle of 30 Tablets with Child Resistant Closure (CRC). NDC 72187-0102-3
Elacestrant 86 mg (equivalent to 100 mg elacestrant dihydrochloride) Light blue; Round “ME” Bottle of 30 Tablets with Child Resistant Closure (CRC). NDC 72187-0101-3

ORSERDU is a trademark of the Menarini Group.
Stemline Therapeutics, Inc., a Menarini Group company
Manufactured for: Stemline Therapeutics, Inc., New York, NY 10022

Drugs

Drug Countries
ORSERDU Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United States
 
Next: Usage >

© 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.

⇈