Hydromorphone Hydrochloride Tablet
NDC Package 42858-302-01

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 is hydromorphone Hydrochloride Oral Solution, USP and Hydromorphone Hydrochloride Tablets, USP are indicated for the management of pain in patients where an opioid analgesic is appropriate. This formulation utilizes a tablet delivery system. Marketed by Rhodes Pharmaceuticals Llc, this product is identified by NDC 42858-302 and is authorized under FDA application NDA019892.

Identification & Billing

NDC Package Code
42858-302-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
42858-302
11-Digit Billing Format
42858030201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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 Oral Solution, USP and Hydromorphone Hydrochloride Tablets, USP are indicated for the management of pain in patients where an opioid analgesic is appropriate.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Rhodes Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA019892
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
11-23-2009
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42858-302). Click a package code to view its specific billing and regulatory data.

42858-302-25
4 BLISTER PACK in 1 CARTON / 25 TABLET in 1 BLISTER PACK
42858-302-50
500 TABLET in 1 BOTTLE, PLASTIC

* 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 42858-302-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Hydromorphone Hydrochloride, a human prescription drug labeled by Rhodes Pharmaceuticals Llc. 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 Rhodes Pharmaceuticals Llc on November 23, 2009. The current certification is valid through December 31, 2027.

How is this Rhodes Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42858030201. 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 (5-3-2)
42858-302-01
11-Digit CMS (5-4-2)
42858-0302-01

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