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  5. NDC Package Code: 70518-3601-0 Duloxetine

NDC Package 70518-3601-0 Duloxetine

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

Table of Contents

    1. Package Information
    2. 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:
70518-3601-0
Package Description:
30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Product Code:
70518-3601
Proprietary Name:
Duloxetine
Non-Proprietary Name:
Duloxetine
Substance Name:
Duloxetine Hydrochloride
Usage Information:
Duloxetine delayed-release capsules are indicated for the treatment of: • Major depressive disorder in adults • Generalized anxiety disorder in adults and pediatric patients 7 years of age and older • Diabetic peripheral neuropathic pain in adults • Fibromya lgia in adults • Chronic musculoskeletal pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
11-Digit NDC Billing Format:
70518360100
NDC to RxNorm Crosswalk:
  • RxCUI: 596926 - DULoxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG Delayed Release Oral Capsule
  • RxCUI: 596926 - duloxetine 20 MG (as duloxetine HCl 22.4 MG) Delayed Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Remedyrepack Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DULOXETINE HYDROCHLORIDE 20 mg/1
    • Pharmacologic Class(es):
  • Norepinephrine Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Serotonin and Norepinephrine Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204343
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-30-2022
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 70518-3601-0?

    The NDC Packaged Code 70518-3601-0 is assigned to a package of 30 capsule, delayed release in 1 blister pack of Duloxetine, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is capsule, delayed release and is administered via oral form.

    Is NDC 70518-3601 included in the NDC Directory?

    Yes, Duloxetine with product code 70518-3601 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on December 30, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70518-3601-0?

    The 11-digit format is 70518360100. 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 5-4-1 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
    5-4-170518-3601-05-4-270518-3601-00