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  5. NDC Package Code: 42858-416-16 Dilaudid

NDC Package 42858-416-16 Dilaudid

Hydromorphone Hydrochloride Solution 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:
42858-416-16
Package Description:
473 mL in 1 BOTTLE, PLASTIC
Product Code:
42858-416
Proprietary Name:
Dilaudid
Non-Proprietary Name:
Hydromorphone Hydrochloride
Substance Name:
Hydromorphone Hydrochloride
Usage Information:
This medication is used to help relieve moderate to severe pain. Hydromorphone belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.
11-Digit NDC Billing Format:
42858041616
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 897657 - HYDROmorphone HCl 1 MG in 1 mL Oral Solution
  • RxCUI: 897657 - hydromorphone hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 897657 - hydromorphone HCl 1 MG per 1 ML Oral Solution
  • RxCUI: 897657 - hydromorphone HCl 5 MG per 5 ML Oral Solution
  • RxCUI: 897658 - Dilaudid 1 MG in 1 mL Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rhodes Pharmaceuticals L.p.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA019891
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-15-2017
    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 42858-416-16?

    The NDC Packaged Code 42858-416-16 is assigned to a package of 473 ml in 1 bottle, plastic of Dilaudid, a human prescription drug labeled by Rhodes Pharmaceuticals L.p.. The product's dosage form is solution and is administered via oral form.

    Is NDC 42858-416 included in the NDC Directory?

    Yes, Dilaudid with product code 42858-416 is active and included in the NDC Directory. The product was first marketed by Rhodes Pharmaceuticals L.p. on May 15, 2017 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 NDC billing unit for package 42858-416-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

    What is the 11-digit format for NDC 42858-416-16?

    The 11-digit format is 42858041616. 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
    5-3-242858-416-165-4-242858-0416-16