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  5. NDC Package Code: 53097-573-60 Marinol

NDC Package 53097-573-60 Marinol

Dronabinol Capsule 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:
53097-573-60
Package Description:
60 CAPSULE in 1 BOTTLE
Product Code:
53097-573
Proprietary Name:
Marinol
Non-Proprietary Name:
Dronabinol
Substance Name:
Dronabinol
Usage Information:
Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is usually used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients with HIV infection. Dronabinol (also called THC) is a man-made form of the active natural substance in marijuana (cannabis).
11-Digit NDC Billing Format:
53097057360
NDC to RxNorm Crosswalk:
  • RxCUI: 197634 - droNABinol 10 MG Oral Capsule
  • RxCUI: 197634 - dronabinol 10 MG Oral Capsule
  • RxCUI: 197635 - droNABinol 2.5 MG Oral Capsule
  • RxCUI: 197635 - dronabinol 2.5 MG Oral Capsule
  • RxCUI: 197636 - droNABinol 5 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Thepharmanetwork, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DRONABINOL 10 mg/1
    • Pharmacologic Class(es):
  • Cannabinoid - [EPC] (Established Pharmacologic Class)
  • Cannabinoids - [CS]
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA018651
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-03-2021
    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 53097-573-60?

    The NDC Packaged Code 53097-573-60 is assigned to a package of 60 capsule in 1 bottle of Marinol, a human prescription drug labeled by Thepharmanetwork, Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 53097-573 included in the NDC Directory?

    Yes, Marinol with product code 53097-573 is active and included in the NDC Directory. The product was first marketed by Thepharmanetwork, Llc on March 03, 2021 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 53097-573-60?

    The 11-digit format is 53097057360. 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
    5-3-253097-573-605-4-253097-0573-60