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  5. NDC Package Code: 69489-201-03 Amzeeq

NDC Package 69489-201-03 Amzeeq

Minocycline Aerosol, Foam Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
69489-201-03
Package Description:
1 CAN in 1 CARTON / 3 g in 1 CAN
Product Code:
69489-201
Proprietary Name:
Amzeeq
Non-Proprietary Name:
Minocycline
Substance Name:
Minocycline Hydrochloride
Usage Information:
AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [see Clinical Studies (14)].Limitations of UseThis formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [see Warnings and Precautions (5.14)].
11-Digit NDC Billing Format:
69489020103
NDC to RxNorm Crosswalk:
  • RxCUI: 2257673 - minocycline 4 % Topical Foam
  • RxCUI: 2257673 - minocycline 40 MG/ML Topical Foam
  • RxCUI: 2257673 - minocycline (as minocycline HCl) 4 % Topical Foam
  • RxCUI: 2257678 - amzeeq 4 % Topical Foam
  • RxCUI: 2257678 - minocycline 40 MG/ML Topical Foam [Amzeeq]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Journey Medical Corporation
    Dosage Form:
    Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
    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):
  • MINOCYCLINE HYDROCHLORIDE 40 mg/g
    • Pharmacologic Class(es):
  • Decreased Prothrombin Activity - [PE] (Physiologic Effect)
  • Tetracycline-class Drug - [EPC] (Established Pharmacologic Class)
  • Tetracyclines - [CS]
    • Sample Package:
    Yes
    FDA Application Number:
    NDA212379
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-25-2022
    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
    69489-201-301 CAN in 1 CARTON / 30 g in 1 CAN

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69489-201-03?

    The NDC Packaged Code 69489-201-03 is assigned to a package of 1 can in 1 carton / 3 g in 1 can of Amzeeq, a human prescription drug labeled by Journey Medical Corporation. The product's dosage form is aerosol, foam and is administered via topical form.

    Is NDC 69489-201 included in the NDC Directory?

    Yes, Amzeeq with product code 69489-201 is active and included in the NDC Directory. The product was first marketed by Journey Medical Corporation on March 25, 2022 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 69489-201-03?

    The 11-digit format is 69489020103. 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
    5-3-269489-201-035-4-269489-0201-03