NDC Package 46708-278-30 Duloxetine Hydrochloride

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

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:
46708-278-30
Package Description:
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Duloxetine Hydrochloride
Non-Proprietary Name:
Duloxetine
Substance Name:
Duloxetine Hydrochloride
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)]
11-Digit NDC Billing Format:
46708027830
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
  • RxCUI: 596930 - DULoxetine 30 MG Delayed Release Oral Capsule
  • RxCUI: 596930 - duloxetine 30 MG Delayed Release Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alembic Pharmaceuticals Limited
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA202949
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-09-2014
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    46708-278-10100 CAPSULE, DELAYED RELEASE in 1 CARTON
    46708-278-6060 CAPSULE, DELAYED RELEASE in 1 BOTTLE
    46708-278-911000 CAPSULE, DELAYED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 46708-278-30?

    The NDC Packaged Code 46708-278-30 is assigned to a package of 30 capsule, delayed release in 1 bottle of Duloxetine Hydrochloride, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is capsule, delayed release and is administered via oral form.

    Is NDC 46708-278 included in the NDC Directory?

    Yes, Duloxetine Hydrochloride with product code 46708-278 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on June 09, 2014 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 46708-278-30?

    The 11-digit format is 46708027830. 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
    5-3-246708-278-305-4-246708-0278-30