Duloxetine Capsule, Delayed Release
NDC Package 70518-1011-2

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

Duloxetine capsules is duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)]. This formulation utilizes a capsule, delayed release delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-1011 and is authorized under FDA application ANDA208706.

Identification & Billing

NDC Package Code
70518-1011-2
Package Description
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
70518-1011
11-Digit Billing Format
70518101102
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
Non-Proprietary Name
Duloxetine
Substance Name
Duloxetine Hydrochloride
Dosage Form
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DULOXETINE HYDROCHLORIDE 60 mg/1
Pharmacologic Class
Usage Information
Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies (14.1)]. Generalized Anxiety Disorder [see Clinical Studies (14.2)]. Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208706
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-12-2018
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70518-1011). Click a package code to view its specific billing and regulatory data.

70518-1011-0
30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
70518-1011-1
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC

* 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 70518-1011-2 identifies a specific commercial package of 60 capsule, delayed release in 1 bottle, plastic of Duloxetine, a human prescription drug labeled by Remedyrepack Inc.. This capsule, delayed release is formulated for oral use and contains duloxetine 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 February 12, 2018. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518101102. 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)
70518-1011-2
11-Digit CMS (5-4-2)
70518-1011-02

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