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  5. NDC Package Code: 16714-628-01 Ciprofloxacin And Dexamethasone

NDC Package 16714-628-01 Ciprofloxacin And Dexamethasone

Suspension/ Drops Auricular (otic) - 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:
16714-628-01
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 7.5 mL in 1 BOTTLE, DROPPER
Product Code:
16714-628
Proprietary Name:
Ciprofloxacin And Dexamethasone
Non-Proprietary Name:
Ciprofloxacin And Dexamethasone
Substance Name:
Ciprofloxacin Hydrochloride; Dexamethasone
Usage Information:
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
11-Digit NDC Billing Format:
16714062801
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Northstar Rxllc
    Dosage Form:
    Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
    Administration Route(s):
  • Auricular (otic) - Administration to or by way of the ear.
    • Active Ingredient(s):
  • CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL
  • DEXAMETHASONE 1 mg/mL
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Quinolone Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Quinolones - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA205548
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-01-2022
    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.

    Frequently Asked Questions

    What is NDC 16714-628-01?

    The NDC Packaged Code 16714-628-01 is assigned to a package of 1 bottle, dropper in 1 carton / 7.5 ml in 1 bottle, dropper of Ciprofloxacin And Dexamethasone, a human prescription drug labeled by Northstar Rxllc. The product's dosage form is suspension/ drops and is administered via auricular (otic) form.

    Is NDC 16714-628 included in the NDC Directory?

    Yes, Ciprofloxacin And Dexamethasone with product code 16714-628 is active and included in the NDC Directory. The product was first marketed by Northstar Rxllc on August 01, 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 NDC billing unit for package 16714-628-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 16714-628-01?

    The 11-digit format is 16714062801. 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
    5-3-216714-628-015-4-216714-0628-01