Amphotericin B Injection, Powder, Lyophilized, For Solution
NDC Package 65044-7183-1

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Amphotericin B injection is see also Warning section. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Jubilant Hollisterstier Llc, this product is identified by NDC 65044-7183.

Identification & Billing

NDC Package Code
65044-7183-1
Package Description
12.5 mL in 1 VIAL, SINGLE-DOSE
Product Code
65044-7183
11-Digit Billing Format
65044718301

Clinical Specifications

Proprietary Name
Amphotericin B
Non-Proprietary Name
Amphotericin B
Substance Name
Amphotericin B
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Active Ingredient(s)
AMPHOTERICIN B 50 mg/12.5mL
Usage Information
See also Warning section. This medication is used to treat a variety of serious, possibly fatal fungal infections. It works by stopping the growth of fungi.

Regulatory & Marketing

Labeler Name
Jubilant Hollisterstier Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-23-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65044-7183-1 identifies a specific commercial package of 12.5 ml in 1 vial, single-dose of Amphotericin B (UNFINISHED drug), drug for further processing labeled by Jubilant Hollisterstier Llc. This injection, powder, lyophilized, for solution is formulated for use and contains amphotericin b 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 Jubilant Hollisterstier Llc on September 23, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

See also Warning section. This medication is used to treat a variety of serious, possibly fatal fungal infections. It works by stopping the growth of fungi.

How is this Jubilant Hollisterstier Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65044718301. 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 (5-4-1)
65044-7183-1
11-Digit CMS (5-4-2)
65044-7183-01

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