Simtriyo Capsule, Extended Release
NDC Package 59148-303-13

11-digit billing NDC: 59148030313
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Simtriyo (centanafadine hydrochloride) capsules is sIMTRIYO is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older weighing at least 20 kg.Limitations of UseThe use of SIMTRIYO is not recommended in pediatric patients:Younger than 6 years of age because this pediatric subpopulation had a higher incidence of weight loss than pediatric patients 6 years of age and older [see Use in Specific Populations (8.4)].Weighing less than 20 kg because of a lack of data for this subpopulation and the risk of weight loss [see Use in Specific Populations (8.4)]. This formulation utilizes a capsule, extended release delivery system. Marketed by Otsuka America Pharmaceutical, Inc., this product is identified by NDC 59148-303 and is authorized under FDA application NDA218145.

Identification & Billing

NDC Package Code
59148-303-13
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
59148-303
11-Digit Billing Format
59148030313

Clinical Specifications

Proprietary Name
Simtriyo
Non-Proprietary Name
Centanafadine Hydrochloride
Substance Name
Centanafadine Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CENTANAFADINE HYDROCHLORIDE 210 mg/1
Usage Information
SIMTRIYO is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older weighing at least 20 kg.Limitations of UseThe use of SIMTRIYO is not recommended in pediatric patients:Younger than 6 years of age because this pediatric subpopulation had a higher incidence of weight loss than pediatric patients 6 years of age and older [see Use in Specific Populations (8.4)].Weighing less than 20 kg because of a lack of data for this subpopulation and the risk of weight loss [see Use in Specific Populations (8.4)].

Regulatory & Marketing

Labeler Name
Otsuka America Pharmaceutical, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218145
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-24-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59148-303). Click a package code to view its specific billing and regulatory data.

59148-303-07
2 BLISTER PACK in 1 CARTON / 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59148-303-13 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Simtriyo, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc.. This capsule, extended release is formulated for oral use and contains centanafadine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Otsuka America Pharmaceutical, Inc. on October 24, 2026. The current certification is valid through December 31, 2027.

How is this Otsuka America Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59148030313. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59148-303-13
11-Digit CMS (5-4-2)
59148-0303-13

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.