1. Home
  2. Labeler Index
  3. Ascent Pharmaceuticals, Inc.
  4. 43602-266
  5. NDC Package Code: 43602-266-05 Hydromorphone Hydrochloride

NDC Package 43602-266-05 Hydromorphone Hydrochloride

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
43602-266-05
Package Description:
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
43602-266
Proprietary Name:
Hydromorphone Hydrochloride
Non-Proprietary Name:
Hydromorphone Hydrochloride
Substance Name:
Hydromorphone Hydrochloride
Usage Information:
Hydromorphone hydrochloride extended-release tablets are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Hydromorphone hydrochloride extended-release tablets is not indicated as an as-needed (prn) analgesic.
11-Digit NDC Billing Format:
43602026605
NDC to RxNorm Crosswalk:
  • RxCUI: 1306898 - HYDROmorphone HCl 32 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1306898 - 24 HR hydromorphone hydrochloride 32 MG Extended Release Oral Tablet
  • RxCUI: 1306898 - hydromorphone hydrochloride 32 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 902729 - HYDROmorphone HCl 12 MG 24HR Extended Release Oral Tablet
  • RxCUI: 902729 - 24 HR hydromorphone hydrochloride 12 MG Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ascent Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HYDROMORPHONE HYDROCHLORIDE 8 mg/1
    • 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:
    ANDA212133
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-24-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43602-266-3030 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43602-266-05?

    The NDC Packaged Code 43602-266-05 is assigned to a package of 500 tablet, extended release in 1 bottle of Hydromorphone Hydrochloride, a human prescription drug labeled by Ascent Pharmaceuticals, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 43602-266 included in the NDC Directory?

    Yes, Hydromorphone Hydrochloride with product code 43602-266 is active and included in the NDC Directory. The product was first marketed by Ascent Pharmaceuticals, Inc. on September 24, 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 43602-266-05?

    The 11-digit format is 43602026605. 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
    5-3-243602-266-055-4-243602-0266-05