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  5. NDC Package Code: 65162-411-03 Levomilnacipran

NDC Package 65162-411-03 Levomilnacipran

Capsule, Extended 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:
65162-411-03
Package Description:
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
65162-411
Proprietary Name:
Levomilnacipran
Non-Proprietary Name:
Levomilnacipran
Substance Name:
Levomilnacipran Hydrochloride
Usage Information:
Levomilnacipran, a serotonin and norepinephrine reuptake inhibitor (SNRI) is indicated for the treatment of major depressive disorder (MDD). The efficacy of levomilnacipran extended-release capsules was established in three 8-week, randomized, double-blind, placebo-controlled studies in adult patients with a diagnosis of MDD [see Clinical Studies (14)]. Limitation of Use: Levomilnacipran extended-release capsules are not approved for the management of fibromyalgia. The efficacy and safety of levomilnacipran extended-release capsules for the management of fibromyalgia have not been established.
11-Digit NDC Billing Format:
65162041103
NDC to RxNorm Crosswalk:
  • RxCUI: 1433217 - levomilnacipran 120 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1433217 - 24 HR levomilnacipran 120 MG Extended Release Oral Capsule
  • RxCUI: 1433217 - levomilnacipran 120 MG (as levomilnacipran hydrochloride 137.8 MG) 24 HR Extended Release Oral Capsule
  • RxCUI: 1433227 - levomilnacipran 20 MG 24HR Extended Release Oral Capsule
  • RxCUI: 1433227 - 24 HR levomilnacipran 20 MG Extended Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Capsule, Extended 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) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LEVOMILNACIPRAN 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:
    ANDA210790
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-04-2019
    Listing Expiration Date:
    12-31-2024
    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 65162-411-03?

    The NDC Packaged Code 65162-411-03 is assigned to a package of 30 capsule, extended release in 1 bottle of Levomilnacipran, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 65162-411 included in the NDC Directory?

    Yes, Levomilnacipran with product code 65162-411 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on February 04, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65162-411-03?

    The 11-digit format is 65162041103. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265162-411-035-4-265162-0411-03