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  5. NDC Package Code: 0641-6254-01 Hydromorphone Hydrochloride

NDC Package 0641-6254-01 Hydromorphone Hydrochloride

Injection, Solution Intramuscular; Intravenous; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
0641-6254-01
Package Description:
1 VIAL in 1 CARTON / 20 mL in 1 VIAL
Product Code:
0641-6254
Proprietary Name:
Hydromorphone Hydrochloride
Non-Proprietary Name:
Hydromorphone Hydrochloride
Substance Name:
Hydromorphone Hydrochloride
Usage Information:
Hydromorphone Hydrochloride Injection is 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, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve Hydromorphone Hydrochloride Injection 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 toleratedHave not provided adequate analgesia or are not expected to provide adequate analgesiaHydromorphone Hydrochloride Injection should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
11-Digit NDC Billing Format:
00641625401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Hikma Pharmaceuticals Usa Inc.
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s):
HYDROMORPHONE HYDROCHLORIDE 2 mg/mL
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
NDA217812
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
05-13-2025
Listing Expiration Date:
12-31-2026
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.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0641-6254-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00641625401J1171INJECTION, HYDROMORPHONE, 0.1 MG0.1 MG20ML

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0641-6254-01?

The NDC Packaged Code 0641-6254-01 is assigned to a package of 1 vial in 1 carton / 20 ml in 1 vial of Hydromorphone Hydrochloride, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subcutaneous form.

Is NDC 0641-6254 included in the NDC Directory?

Yes, Hydromorphone Hydrochloride with product code 0641-6254 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on May 13, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0641-6254-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 0641-6254-01?

The 11-digit format is 00641625401. 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 4-4-2 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
4-4-20641-6254-015-4-200641-6254-01