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  5. NDC Package Code: 0378-9121-98 Fentanyl

NDC Package 0378-9121-98 Fentanyl

Patch Transdermal - 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:
0378-9121-98
Package Description:
5 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0378-9121-16) / 72 h in 1 PATCH
Product Code:
0378-9121
Proprietary Name:
Fentanyl
Non-Proprietary Name:
Fentanyl
Substance Name:
Fentanyl
Usage Information:
This medication is used to help relieve severe ongoing pain (such as due to cancer). Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use the patch form of fentanyl to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
11-Digit NDC Billing Format:
00378912198
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1603495 - fentaNYL 37.5 MCG/HR 72HR Transdermal System
  • RxCUI: 1603495 - 72 HR fentanyl 0.0375 MG/HR Transdermal System
  • RxCUI: 1603495 - fentanyl 37.5 MCG/HR 3 Day Transdermal Patch
  • RxCUI: 1603498 - fentaNYL 62.5 MCG/HR 72 HR Transdermal System
  • RxCUI: 1603498 - 72 HR fentanyl 0.0625 MG/HR Transdermal System
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • FENTANYL 25 ug/h
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA076258
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-31-2005
    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 0378-9121-98?

    The NDC Packaged Code 0378-9121-98 is assigned to a package of 5 pouch in 1 carton / 1 patch in 1 pouch (0378-9121-16) / 72 h in 1 patch of Fentanyl, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is patch and is administered via transdermal form.

    Is NDC 0378-9121 included in the NDC Directory?

    Yes, Fentanyl with product code 0378-9121 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on January 31, 2005 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 0378-9121-98?

    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 1.

    What is the 11-digit format for NDC 0378-9121-98?

    The 11-digit format is 00378912198. 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 4-4-2 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
    4-4-20378-9121-985-4-200378-9121-98