Amphotericin B Injectable, Liposomal
NDC Package 62756-233-02

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

Amphotericin B injectables is see also Warning section. This formulation utilizes a injectable, liposomal delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 62756-233 and is authorized under FDA application ANDA212514.

Identification & Billing

NDC Package Code
62756-233-02
Package Description
10 CARTON in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE
Product Code
62756-233
11-Digit Billing Format
62756023302
RxNorm Crosswalk
RxCUI: 967385 - amphotericin B liposomal 50 MG Injection

Clinical Specifications

Proprietary Name
Amphotericin B
Non-Proprietary Name
Amphotericin B
Substance Name
Amphotericin B
Dosage Form
Injectable, Liposomal - An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance).
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
AMPHOTERICIN B 50 mg/1
Pharmacologic Class
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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212514
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-09-2022
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 (62756-233). Click a package code to view its specific billing and regulatory data.

62756-233-01
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE

* 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 62756-233-02 identifies a specific commercial package of 10 carton in 1 carton / 1 vial, single-dose in 1 carton / 1 injectable, liposomal in 1 vial, single-dose of Amphotericin B, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This injectable, liposomal is formulated for intravenous 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 Sun Pharmaceutical Industries, Inc. on February 09, 2022. The current certification is valid through December 31, 2027.

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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62756023302. 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)
62756-233-02
11-Digit CMS (5-4-2)
62756-0233-02

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