Hydromorphone Hydrochloride Tablet
NDC Package 43602-003-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Hydromorphone Hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia, or are not expected to provide adequate analgesia. This formulation utilizes a tablet delivery system. Marketed by Ascent Pharmaceuticals Inc, this product is identified by NDC 43602-003 and is authorized under FDA application ANDA210506.

Identification & Billing

NDC Package Code
43602-003-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
43602-003
11-Digit Billing Format
43602000330
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydromorphone Hydrochloride
Non-Proprietary Name
Hydromorphone Hydrochloride
Substance Name
Hydromorphone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROMORPHONE HYDROCHLORIDE 4 mg/1
Pharmacologic Class
Usage Information
Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia, or are not expected to provide adequate analgesia
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Ascent Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA210506
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-24-2018
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43602-003). Click a package code to view its specific billing and regulatory data.

43602-003-05
500 TABLET in 1 BOTTLE

* 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 43602-003-30 identifies a specific commercial package of 30 tablet in 1 bottle of Hydromorphone Hydrochloride, a human prescription drug labeled by Ascent Pharmaceuticals Inc. This tablet 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 Ascent Pharmaceuticals Inc on January 24, 2018. The current certification is valid through December 31, 2026.

How is this Ascent Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43602000330. 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 (5-3-2)
43602-003-30
11-Digit CMS (5-4-2)
43602-0003-30

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