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  5. NDC Package Code: 70681-001-30 Ammonia N 13

NDC Package 70681-001-30 Ammonia N 13

Ammonia N-13 Injection, Solution Intravenous - 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:
70681-001-30
Package Description:
30 mL in 1 VIAL, GLASS
Product Code:
70681-001
Proprietary Name:
Ammonia N 13
Non-Proprietary Name:
Ammonia N-13
Substance Name:
Ammonia N-13
Usage Information:
Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
11-Digit NDC Billing Format:
70681000130
Product Type:
Human Prescription Drug
Labeler Name:
The University Of Texas Southwestern Medical Center
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • AMMONIA N-13 37.5 mCi/mL
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209507
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-01-2020
    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 70681-001-30?

    The NDC Packaged Code 70681-001-30 is assigned to a package of 30 ml in 1 vial, glass of Ammonia N 13, a human prescription drug labeled by The University Of Texas Southwestern Medical Center. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 70681-001 included in the NDC Directory?

    Yes, Ammonia N 13 with product code 70681-001 is active and included in the NDC Directory. The product was first marketed by The University Of Texas Southwestern Medical Center on May 01, 2020 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 70681-001-30?

    The 11-digit format is 70681000130. 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
    5-3-270681-001-305-4-270681-0001-30