1. Home
  2. Labeler Index
  3. Armas Pharmaceuticals Inc.
  4. 72485-630
  5. NDC Package Code: 72485-630-05 Loteprednol Etabonate

NDC Package 72485-630-05 Loteprednol Etabonate

Gel Ophthalmic - 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:
72485-630-05
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 5 g in 1 BOTTLE, DROPPER
Product Code:
72485-630
Proprietary Name:
Loteprednol Etabonate
Non-Proprietary Name:
Loteprednol Etabonate
Substance Name:
Loteprednol Etabonate
Usage Information:
This medication is used to treat certain eye conditions due to inflammation or injury. It is also used after eye surgery. Loteprednol works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.
11-Digit NDC Billing Format:
72485063005
NDC to RxNorm Crosswalk:
  • RxCUI: 1312625 - loteprednol etabonate 0.5 % Ophthalmic Gel
  • RxCUI: 1312625 - loteprednol etabonate 0.005 MG/MG Ophthalmic Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Armas 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):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • LOTEPREDNOL ETABONATE 5 mg/g
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA212080
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-25-2023
    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.

    Frequently Asked Questions

    What is NDC 72485-630-05?

    The NDC Packaged Code 72485-630-05 is assigned to a package of 1 bottle, dropper in 1 carton / 5 g in 1 bottle, dropper of Loteprednol Etabonate, a human prescription drug labeled by Armas Pharmaceuticals Inc.. The product's dosage form is gel and is administered via ophthalmic form.

    Is NDC 72485-630 included in the NDC Directory?

    Yes, Loteprednol Etabonate with product code 72485-630 is active and included in the NDC Directory. The product was first marketed by Armas Pharmaceuticals Inc. on October 25, 2023 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 72485-630-05?

    The 11-digit format is 72485063005. 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
    5-3-272485-630-055-4-272485-0630-05