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  5. NDC Package Code: 70518-3738-0 Moxifloxacin Hydrochloride

NDC Package 70518-3738-0 Moxifloxacin Hydrochloride

Tablet, Film Coated Oral - 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:
70518-3738-0
Package Description:
7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
70518-3738
Proprietary Name:
Moxifloxacin Hydrochloride
Non-Proprietary Name:
Moxifloxacin Hydrochloride
Substance Name:
Moxifloxacin Hydrochloride
Usage Information:
Moxifloxacin;tablets are indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]) , Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies (14.3)] . MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
11-Digit NDC Billing Format:
70518373800
NDC to RxNorm Crosswalk:
  • RxCUI: 311787 - moxifloxacin HCl 400 MG Oral Tablet
  • RxCUI: 311787 - moxifloxacin 400 MG Oral Tablet
  • RxCUI: 311787 - moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Remedyrepack Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MOXIFLOXACIN HYDROCHLORIDE 400 mg/1
    • Pharmacologic Class(es):
  • Fluoroquinolone Antibacterial - [EPC] (Established Pharmacologic Class)
  • Fluoroquinolones - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA202632
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-30-2023
    Listing Expiration Date:
    12-31-2025
    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 70518-3738-0?

    The NDC Packaged Code 70518-3738-0 is assigned to a package of 7 tablet, film coated in 1 bottle, plastic of Moxifloxacin Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 70518-3738 included in the NDC Directory?

    Yes, Moxifloxacin Hydrochloride with product code 70518-3738 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on May 30, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70518-3738-0?

    The 11-digit format is 70518373800. 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 5-4-1 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
    5-4-170518-3738-05-4-270518-3738-00