Duramorph Injection
NDC Package 0641-6019-10
Package Information
Duramorph (morphine sulfate) injection is a medication used to treat severe pain. This formulation utilizes a injection delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0641-6019 and is authorized under FDA application NDA018565.
Identification & Billing
- RxCUI: 1728783 - morphine sulfate 5 MG in 10 ML Injection
- RxCUI: 1728783 - 10 ML morphine sulfate 0.5 MG/ML Injection
- RxCUI: 1728783 - 10 ML MS 0.5 MG/ML Injection
- RxCUI: 1728783 - morphine sulfate 5 MG per 10 ML Injection
- RxCUI: 1728800 - morphine sulfate 10 MG in 10 ML Injection
Clinical Specifications
- Epidural - Administration upon or over the dura mater.
- Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
- Intravenous - Administration within or into a vein or veins.
Regulatory & Marketing
Hierarchy Structure
- 0641 - Hikma Pharmaceuticals Usa Inc.
- 0641-6019 - Duramorph
- 0641-6019-10 - 10 AMPULE in 1 CARTON / 10 mL in 1 AMPULE (0641-6019-01)
- 0641-6019 - Duramorph
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 0641-6019-10 identifies a specific commercial package of 10 ampule in 1 carton / 10 ml in 1 ampule (0641-6019-01) of Duramorph, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection is formulated for epidural; intrathecal; intravenous use and contains morphine sulfate 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 Hikma Pharmaceuticals Usa Inc. on September 18, 1984. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used to treat severe pain. Morphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.
How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00641601910. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
