Duloxetine Hydrochloride
NDC Package 61919-042-60

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

Package Information

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

Duloxetine Hydrochloride is 1.1 Major Depressive DisorderDuloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). Marketed by Direct_rx, this product is identified by NDC 61919-042 and is authorized under FDA application ANDA203088.

Identification & Billing

NDC Package Code
61919-042-60
Package Description
60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code
61919-042
11-Digit Billing Format
61919004260
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 596934 - DULoxetine 60 MG Delayed Release Oral Capsule
  • RxCUI: 596934 - duloxetine 60 MG Delayed Release Oral Capsule
  • RxCUI: 596934 - duloxetine 60 MG (as duloxetine HCl 67.3 MG) Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Duloxetine Hydrochloride
Dosage Form
-
Usage Information
1.1 Major Depressive DisorderDuloxetine 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.1.2 Generalized Anxiety DisorderDuloxetine Delayed-release Capsules are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Duloxetine Delayed-release Capsules was established in three short-term trials and one maintenance trial in adults [see Clinical Studies (14.2)]. Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.1.3 Diabetic Peripheral Neuropathic PainDuloxetine Delayed-release Capsules are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies (14.3)]. 1.5 Chronic Musculoskeletal PainDuloxetine Delayed-release Capsules are indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis [see Clinical Studies (14.5)].

Regulatory & Marketing

Labeler Name
Direct_rx
FDA Application #
ANDA203088
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-16-2019
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61919-042). Click a package code to view its specific billing and regulatory data.

61919-042-30
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
61919-042-90
90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE

* 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 61919-042-60 identifies a specific commercial package of 60 capsule, delayed release pellets in 1 bottle of Duloxetine Hydrochloride, labeled by Direct_rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Direct_rx on August 16, 2019. The current certification is valid through December 31, 2022.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919004260. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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)
61919-042-60
11-Digit CMS (5-4-2)
61919-0042-60

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