NDC Package 0378-8086-45 Tretinoin

Gel Topical - 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:
0378-8086-45
Package Description:
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code:
Proprietary Name:
Tretinoin
Non-Proprietary Name:
Tretinoin
Substance Name:
Tretinoin
Usage Information:
This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.
11-Digit NDC Billing Format:
00378808645
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
45 GM
Product Type:
Human Prescription Drug
Labeler Name:
Mylan Pharmaceuticals Inc.
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA017579
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    07-12-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0378-8086-151 TUBE in 1 CARTON / 15 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-8086-45?

    The NDC Packaged Code 0378-8086-45 is assigned to a package of 1 tube in 1 carton / 45 g in 1 tube of Tretinoin, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is gel and is administered via topical form.

    Is NDC 0378-8086 included in the NDC Directory?

    Yes, Tretinoin with product code 0378-8086 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on July 12, 2019 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 0378-8086-45?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 45.

    What is the 11-digit format for NDC 0378-8086-45?

    The 11-digit format is 00378808645. 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
    4-4-20378-8086-455-4-200378-8086-45