Melphalan Hydrochloride
NDC Package 45963-686-02
Package Information
Melphalan Hydrochloride is for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. Marketed by Actavis Pharma, Inc., this product is identified by NDC 45963-686 and is authorized under FDA application ANDA206018.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 45963 - Actavis Pharma, Inc.
- 45963-686 - Melphalan Hydrochloride
- 45963-686-02 - 1 KIT in 1 PACKAGE, COMBINATION * 10 mL in 1 VIAL, SINGLE-DOSE (45963-687-49) * 10 mL in 1 VIAL, SINGLE-USE (45963-688-57)
- 45963-686 - Melphalan Hydrochloride
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 45963-686-02 identifies a specific commercial package of 1 kit in 1 package, combination * 10 ml in 1 vial, single-dose (45963-687-49) * 10 ml in 1 vial, single-use (45963-688-57) of Melphalan Hydrochloride, labeled by Actavis Pharma, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Actavis Pharma, Inc. on January 13, 2017. The current certification is valid through April 30, 2026.
How is this Actavis Pharma, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 45963068602. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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 Product segment to maintain the 5-4-2 structure.
