Romidepsin Injection, Solution, Concentrate
NDC Package 70121-2250-1

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

Package Information

Romidepsin injection is romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 70121-2250 and is authorized under FDA application ANDA219099.

Identification & Billing

NDC Package Code
70121-2250-1
Package Description
1 VIAL in 1 CARTON / 5.5 mL in 1 VIAL
Product Code
70121-2250
11-Digit Billing Format
70121225001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Romidepsin
Non-Proprietary Name
Romidepsin
Substance Name
Romidepsin
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ROMIDEPSIN 5 mg/mL
Pharmacologic Class
Usage Information
Romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219099
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70121-2250-1 identifies a specific commercial package of 1 vial in 1 carton / 5.5 ml in 1 vial of Romidepsin, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This injection, solution, concentrate is formulated for intravenous use and contains romidepsin 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 Amneal Pharmaceuticals Llc on June 02, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.

How is this Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70121225001. 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)
70121-2250-1
11-Digit CMS (5-4-2)
70121-2250-01

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