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  5. NDC Package Code: 43538-940-99 Neo-synalar

NDC Package 43538-940-99 Neo-synalar

Neomycin Sulfate And Fluocinolone Acetonide Cream 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:
43538-940-99
Package Description:
4 TUBE in 1 CARTON / 3 g in 1 TUBE
Product Code:
43538-940
Proprietary Name:
Neo-synalar
Non-Proprietary Name:
Neomycin Sulfate And Fluocinolone Acetonide
Substance Name:
Fluocinolone Acetonide; Neomycin Sulfate
Usage Information:
This medication is used to treat certain skin infections. This product contains neomycin, an antibiotic that works by stopping the growth of bacteria. It also contains fluocinolone, a medium-strength corticosteroid that helps to reduce swelling, itching, and redness of the skin. This medication treats only bacterial skin infections. It will not work for other types of skin infections (such as infections caused by fungi, viruses). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
11-Digit NDC Billing Format:
43538094099
NDC to RxNorm Crosswalk:
  • RxCUI: 1191359 - neomycin sulfate 0.5 % / fluocinolone acetonide 0.025 % Topical Cream
  • RxCUI: 1191359 - fluocinolone acetonide 0.25 MG/ML / neomycin sulfate 5 MG/ML Topical Cream
  • RxCUI: 1191359 - fluocinolone acetonide 0.025 % / neomycin sulfate 0.5 % Topical Cream
  • RxCUI: 1542994 - NEO-SYNALAR 0.5 % (0.35 % ) / 0.025 % Topical Cream
  • RxCUI: 1542994 - fluocinolone acetonide 0.25 MG/ML / neomycin sulfate 5 MG/ML Topical Cream [Neo-Synalar]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Medimetriks Pharmaceuticals
    Dosage Form:
    Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    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 .25 mg/g
  • NEOMYCIN SULFATE 3.5 mg/g
    • Pharmacologic Class(es):
  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA060700
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-11-1963
    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
    43538-940-601 TUBE in 1 CARTON / 60 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43538-940-99?

    The NDC Packaged Code 43538-940-99 is assigned to a package of 4 tube in 1 carton / 3 g in 1 tube of Neo-synalar, a human prescription drug labeled by Medimetriks Pharmaceuticals. The product's dosage form is cream and is administered via topical form.

    Is NDC 43538-940 included in the NDC Directory?

    Yes, Neo-synalar with product code 43538-940 is active and included in the NDC Directory. The product was first marketed by Medimetriks Pharmaceuticals on June 11, 1963 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 43538-940-99?

    The 11-digit format is 43538094099. 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
    5-3-243538-940-995-4-243538-0940-99