SIMTRIYO Extended-release capsule Ref.[116784] Active ingredients: Centanafadine

Source: FDA, National Drug Code (US)  Revision Year: 2026 

Product description

SIMTRIYO is a norepinephrine-dopamine-serotonin reuptake inhibitor and central nervous system stimulant. Centanafadine hydrochloride has the chemical designation of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane hydrochloride. The molecular formula is C15H15N•HCl which corresponds to a molecular weight of 245.75 with the following structural formula:

SIMTRIYO (centanafadine) extended-release capsules for oral use contain 140 mg, 210 mg, or 280 mg of centanafadine, equivalent to 164.4 mg, 246.6 mg, or 328.8 mg, respectively, of centanafadine hydrochloride. Each capsule contains a combination of immediate release, extended release, and delayed release beads. Inactive ingredients for the beads include: colloidal silicon dioxide, ethyl acrylate and methyl methacrylate copolymer, hypromellose, mannitol, microcrystalline cellulose, plasacryl, poly (methyl acrylate-CO-methyl methacrylate-CO-methacrylic acid), polysorbate 80, and talc. The capsule shell contains: hypromellose, titanium dioxide, FD&C Blue No. 1 (280 mg capsule), FD&C Yellow No. 5 (210 mg capsule), FD&C Yellow No. 6 (140 mg capsule). The capsules are imprinted with edible black ink.

Dosage Forms and Strengths

Extended-release capsules:

  • 140 mg of centanafadine: capsules with light orange opaque cap (imprinted with "C140") and white opaque body (imprinted with "Otsuka")
  • 210 mg of centanafadine: capsules with yellow opaque cap (imprinted with "C210") and white opaque body (imprinted with "Otsuka")
  • 280 mg of centanafadine: capsules with powder blue opaque cap (imprinted with "C280") and white opaque body (imprinted with "Otsuka")
How Supplied

SIMTRIYO (centanafadine) extended-release capsules are available as follows:

StrengthColorsImprint codesSizeNDC
140 mglight orange opaque
cap/white opaque body
"C140" (cap) and "Otsuka"
(body)
Bottle of 30 59148-302-13
210 mgyellow opaque cap/white
opaque body
"C210" (cap) and "Otsuka"
(body)
Bottle of 30 59148-303-13
280 mgpowder blue opaque
cap/white opaque body
"C280" (cap) and "Otsuka"
(body)
Bottle of 30 59148-304-13

Manufactured for Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA

Drugs

Drug Countries
SIMTRIYO United States

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