JASCAYD Film-coated tablet Ref.[116083] Active ingredients: Nerandomilast

Source: FDA, National Drug Code (US)  Revision Year: 2025 

Product description

JASCAYD (nerandomilast tablets), for oral administration, contain nerandomilast, a phosphodiesterase 4 (PDE4) inhibitor. The chemical name of nerandomilast is [1-[[(5R)-2-[4-(5-chloropyrimidin-2-yl)-1-piperidyl]-5-oxo-6,7-dihydrothieno[3,2-d]pyrimidin-4-yl]amino]cyclobutyl]methanol. Nerandomilast has one chiral center and is the R-stereoisomer. Its structural formula is:

Nerandomilast is a white to off-white to light yellow powder with an empirical formula of C20H25ClN6O2S and a molecular weight of 449 g/mol. At or below pH 3, nerandomilast is very slightly to slightly soluble in water, and above pH 3 it is practically insoluble.

Each film-coated tablet of JASCAYD contains 9 mg or 18 mg of nerandomilast and the following inactive ingredients: croscarmellose sodium, ferric oxide red (18 mg tablets only), ferric oxide yellow (9 mg tablets only), ferrosoferric oxide (18 mg tablets only), hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, and talc. Each JASCAYD tablet contains less than 5 mg of sodium.

Dosage Forms and Strengths

Tablets:

  • 9 mg, light yellow, oval, biconvex, film-coated tablets debossed with the Boehringer Ingelheim company symbol on one side and "F9" on the other side.
  • 18 mg, light red, oval, biconvex, film-coated tablets debossed with the Boehringer Ingelheim company symbol on one side and "F18" on the other side.
How Supplied

JASCAYD tablets are supplied as follows:

Tablet StrengthTablet DescriptionPackage ConfigurationNDC
9 mglight yellow, oval,
biconvex, film-
coated tablets
debossed with the
Boehringer
Ingelheim company
symbol on one side
and "F9" on the
other side
Bottles of 60 with
child-resistant
closure
0597-2465-41
18 mglight red, oval,
biconvex, film-
coated tablets
debossed with the
Boehringer
Ingelheim company
symbol on one side
and "F18" on the
other side
Bottles of 60 with
child-resistant
closure
0597-7313-21

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Drugs

Drug Countries
JASCAYD 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.