Atomoxetine Hydrochloride Capsule
NDC Package 70518-4313-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Atomoxetine Hydrochloride capsules is atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). This formulation utilizes a capsule delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4313 and is authorized under FDA application ANDA078983.

Identification & Billing

NDC Package Code
70518-4313-0
Package Description
30 POUCH in 1 BOX / 1 CAPSULE in 1 POUCH (70518-4313-1)
Product Code
70518-4313
11-Digit Billing Format
70518431300
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Atomoxetine Hydrochloride
Non-Proprietary Name
Atomoxetine Hydrochloride
Substance Name
Atomoxetine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ATOMOXETINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies ( 14)] .

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078983
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-19-2025
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-4313-0 identifies a specific commercial package of 30 pouch in 1 box / 1 capsule in 1 pouch (70518-4313-1) of Atomoxetine Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. This capsule is formulated for oral use and contains atomoxetine 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 Remedyrepack Inc. on March 19, 2025. The current certification is valid through December 31, 2026.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518431300. 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 (5-4-1)
70518-4313-0
11-Digit CMS (5-4-2)
70518-4313-00

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