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  5. NDC Package Code: 63629-9187-1 Duloxetine Delayed-release

NDC Package 63629-9187-1 Duloxetine Delayed-release

Duloxetine Hydrochloride Capsule, Delayed Release Pellets 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:
63629-9187-1
Package Description:
30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE
Product Code:
63629-9187
Proprietary Name:
Duloxetine Delayed-release
Non-Proprietary Name:
Duloxetine Hydrochloride
Substance Name:
Duloxetine Hydrochloride
Usage Information:
Duloxetine delayed-release capsules are indicated for the treatment of:Major depressive disorder in adultsGeneralized anxiety disorder in adults and pediatric patients 7 years of age and olderDiabetic peripheral neuropathic pain in adultsFibromyalgia in adultsChronic musculoskeletal pain in adultsAdditional 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:
63629918701
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 616402 - DULoxetine 40 MG Delayed Release Oral Capsule
  • RxCUI: 616402 - duloxetine 40 MG Delayed Release Oral Capsule
  • RxCUI: 616402 - duloxetine 40 MG (as duloxetine HCl 44.9 MG) Delayed Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DULOXETINE HYDROCHLORIDE 40 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:
    ANDA203088
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-21-2018
    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 63629-9187-1?

    The NDC Packaged Code 63629-9187-1 is assigned to a package of 30 capsule, delayed release pellets in 1 bottle of Duloxetine Delayed-release, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is capsule, delayed release pellets and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 63629-9187 included in the NDC Directory?

    Yes, Duloxetine Delayed-release with product code 63629-9187 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on May 21, 2018 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 NDC billing unit for package 63629-9187-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 63629-9187-1?

    The 11-digit format is 63629918701. 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
    5-4-163629-9187-15-4-263629-9187-01