Anagrelide Capsule
NDC Package 70954-879-10

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

Package Information

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. This formulation utilizes a capsule delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 70954-879 and is authorized under FDA application ANDA076811.

Identification & Billing

NDC Package Code
70954-879-10
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
70954-879
11-Digit Billing Format
70954087910
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Anagrelide
Non-Proprietary Name
Anagrelide
Substance Name
Anagrelide Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ANAGRELIDE HYDROCHLORIDE .5 mg/1
Pharmacologic Class
Usage Information
Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.

Regulatory & Marketing

Labeler Name
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076811
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-06-2025
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 70954-879-10 identifies a specific commercial package of 100 capsule in 1 bottle of Anagrelide, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This capsule is formulated for oral use and contains anagrelide hydrochloride 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 Ani Pharmaceuticals, Inc. on November 06, 2025. The current certification is valid through December 31, 2026.

How is this Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70954087910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
70954-879-10
11-Digit CMS (5-4-2)
70954-0879-10

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