Hydromorphone Hydrochloride Tablet, Extended Release
NDC Package 0574-0295-01

11-digit billing NDC: 00574029501 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydromorphone Hydrochloride tablets is hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.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 Use•Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydromorphone hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.•Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. This formulation utilizes a tablet, extended release delivery system. Marketed by Padagis Us Llc, this product is identified by NDC 0574-0295 and is authorized under FDA application ANDA204278.

Identification & Billing

NDC Package Code
0574-0295-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
0574-0295
11-Digit Billing Format
00574029501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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

Clinical Specifications

Proprietary Name
Hydromorphone Hydrochloride
Non-Proprietary Name
Hydromorphone Hydrochloride
Substance Name
Hydromorphone Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROMORPHONE HYDROCHLORIDE 16 mg/1
Pharmacologic Class
Usage Information
Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.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 Use•Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydromorphone hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.•Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Padagis Us Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204278
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-22-2015
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0574-0295-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Hydromorphone Hydrochloride, a human prescription drug labeled by Padagis Us Llc. This tablet, extended release is formulated for oral use and contains hydromorphone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Padagis Us Llc on May 22, 2015. The current certification is valid through December 31, 2027.

How is this Padagis Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574029501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0574-0295-01
11-Digit CMS (5-4-2)
00574-0295-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.