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  5. NDC Package Code: 64980-331-04 Fluocinolone Acetonide Oil

NDC Package 64980-331-04 Fluocinolone Acetonide Oil

Oil Topical - 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:
64980-331-04
Package Description:
118.28 mL in 1 BOTTLE
Product Code:
64980-331
Proprietary Name:
Fluocinolone Acetonide Oil
Non-Proprietary Name:
Fluocinolone Acetonide
Substance Name:
Fluocinolone Acetonide
Usage Information:
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Fluocinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.
11-Digit NDC Billing Format:
64980033104
NDC to RxNorm Crosswalk:
  • RxCUI: 1191307 - fluocinolone acetonide 0.01 % Topical Oil
  • RxCUI: 1191307 - fluocinolone acetonide 0.1 MG/ML Topical Oil
  • RxCUI: 1191307 - fluocinolone acetonide 0.011 % Topical Oil
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rising Pharmaceuticals, Inc.
    Dosage Form:
    Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
    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):
  • FLUOCINOLONE ACETONIDE .11 mg/mL
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203377
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-18-2016
    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 64980-331-04?

    The NDC Packaged Code 64980-331-04 is assigned to a package of 118.28 ml in 1 bottle of Fluocinolone Acetonide Oil, a human prescription drug labeled by Rising Pharmaceuticals, Inc.. The product's dosage form is oil and is administered via topical form.

    Is NDC 64980-331 included in the NDC Directory?

    Yes, Fluocinolone Acetonide Oil with product code 64980-331 is active and included in the NDC Directory. The product was first marketed by Rising Pharmaceuticals, Inc. on July 18, 2016 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 64980-331-04?

    The 11-digit format is 64980033104. 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
    5-3-264980-331-045-4-264980-0331-04