NDC Package 68382-220-16 Atomoxetine

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

68382-220-16

Package Description:

90 CAPSULE in 1 BOTTLE

Product Code:

68382-220

Proprietary Name:

Atomoxetine

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)].

11-Digit NDC Billing Format:

68382022016

NDC to RxNorm Crosswalk:

RxCUI: 349591 - atomoxetine HCl 10 MG Oral Capsule
RxCUI: 349591 - atomoxetine 10 MG Oral Capsule
RxCUI: 349591 - atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule
RxCUI: 349592 - atomoxetine HCl 18 MG Oral Capsule
RxCUI: 349592 - atomoxetine 18 MG Oral Capsule

Labeler Name:

Zydus Pharmaceuticals Usa Inc.

Sample Package:

FDA Application Number:

ANDA079017

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

06-12-2017

End Marketing Date:

03-21-2025

Listing Expiration Date:

03-21-2025

Exclude Flag:

Code Structure:

68382 - Zydus Pharmaceuticals Usa Inc.
- 68382-220 - Atomoxetine
  - 68382-220-16 - 90 CAPSULE in 1 BOTTLE

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 Code	Package Description
68382-220-02	2000 CAPSULE in 1 BOTTLE
68382-220-06	30 CAPSULE in 1 BOTTLE
68382-220-10	1000 CAPSULE in 1 BOTTLE
68382-220-14	60 CAPSULE in 1 BOTTLE
68382-220-77	10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (68382-220-30)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68382-220-16?

The NDC Packaged Code 68382-220-16 is assigned to a package of 90 capsule in 1 bottle of Atomoxetine, labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is and is administered via form.

Is NDC 68382-220 included in the NDC Directory?

No, Atomoxetine with product code 68382-220 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on June 12, 2017 and its listing in the NDC Directory is set to expire on March 21, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68382-220-16?

The 11-digit format is 68382022016. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	68382-220-16	5-4-2	68382-0220-16

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