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  5. NDC Package Code: 64380-475-01 Atomoxetine

NDC Package 64380-475-01 Atomoxetine

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
64380-475-01
Package Description:
30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
64380-475
Proprietary Name:
Atomoxetine
Non-Proprietary Name:
Atomoxetine
Substance Name:
Atomoxetine Hydrochloride
Usage Information:
Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).The efficacy of atomoxetine is 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)].
11-Digit NDC Billing Format:
64380047501
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Strides Pharma Science Limited
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
ATOMOXETINE HYDROCHLORIDE 40 mg/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA079021
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-01-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
64380-475-02500 CAPSULE in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 64380-475-01?

The NDC Packaged Code 64380-475-01 is assigned to a package of 30 capsule in 1 bottle, plastic of Atomoxetine, a human prescription drug labeled by Strides Pharma Science Limited. The product's dosage form is capsule and is administered via oral form.

Is NDC 64380-475 included in the NDC Directory?

Yes, Atomoxetine with product code 64380-475 is active and included in the NDC Directory. The product was first marketed by Strides Pharma Science Limited on July 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 64380-475-01?

The 11-digit format is 64380047501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-264380-475-015-4-264380-0475-01