Duloxetine
NDC Package 62034-021-77

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Duloxetine is delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). Marketed by Blenheim Pharmacal, Inc., this product is identified by NDC 62034-021 and is authorized under FDA application ANDA203088.

Identification & Billing

NDC Package Code
62034-021-77
Package Description
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (62034-021-11)
Product Code
62034-021
11-Digit Billing Format
62034002177
RxNorm Crosswalk
  • RxCUI: 596930 - DULoxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG (as duloxetine HCl 33.7 MG) Delayed Release Oral Capsule
  • RxCUI: 596934 - DULoxetine 60 MG Delayed Release Oral Capsule
  • RxCUI: 596934 - duloxetine 60 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Duloxetine Delayed-release
Dosage Form
-
Usage Information
Duloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of Duloxetine Delayed-release Capsules was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1)] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

Regulatory & Marketing

Labeler Name
Blenheim Pharmacal, Inc.
FDA Application #
ANDA203088
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2016
Listing Expiration
12-31-2017
Exclude Flag
I
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 62034-021-77 identifies a specific commercial package of 100 blister pack in 1 box, unit-dose / 1 capsule, delayed release pellets in 1 blister pack (62034-021-11) of Duloxetine Delayed-release, labeled by Blenheim Pharmacal, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Blenheim Pharmacal, Inc. on April 01, 2016. The current certification is valid through December 31, 2017.

How is this Blenheim Pharmacal, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62034002177. 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)
62034-021-77
11-Digit CMS (5-4-2)
62034-0021-77

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