Azacitidine Injection, Powder, Lyophilized, For Solution
NDC Package 58458-002-02

11-digit billing NDC: 58458000202
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Azacitidine injection is azacitidine for Injection (Azacitidine), is indicated for treatment of adult patients with the following French-American British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).Pediatric use information is approved for Bristol-Myers Squibb’s Vidaza(azacitidine for injection). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Reliance Life Sciences Private Limited, this product is identified by NDC 58458-002 and is authorized under FDA application ANDA217453.

Identification & Billing

NDC Package Code
58458-002-02
Package Description
1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
Product Code
58458-002
11-Digit Billing Format
58458000202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azacitidine
Non-Proprietary Name
Azacitidine
Substance Name
Azacitidine
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.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
AZACITIDINE 100 mg/1
Pharmacologic Class
Usage Information
Azacitidine for Injection (Azacitidine), is indicated for treatment of adult patients with the following French-American British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).Pediatric use information is approved for Bristol-Myers Squibb’s Vidaza(azacitidine for injection). However, due to Bristol-Myers Squibb’smarketing exclusivity rights, this drug product is not labeled with that information.

Regulatory & Marketing

Labeler Name
Reliance Life Sciences Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA217453
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-30-2025
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58458-002-02 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass of Azacitidine, a human prescription drug labeled by Reliance Life Sciences Private Limited. This injection, powder, lyophilized, for solution is formulated for intravenous; subcutaneous use and contains azacitidine 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 Reliance Life Sciences Private Limited on July 30, 2025. The current certification is valid through December 31, 2026.

How is this Reliance Life Sciences Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58458000202. 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)
58458-002-02
11-Digit CMS (5-4-2)
58458-0002-02

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