Cinacalcet Tablet, Film Coated
NDC Package 64380-883-04

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

Package Information

Cinacalcet tablets is cinacalcet hydrochloride tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Strides Pharma Science Limited, this product is identified by NDC 64380-883 and is authorized under FDA application ANDA209226.

Identification & Billing

NDC Package Code
64380-883-04
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
64380-883
11-Digit Billing Format
64380088304
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cinacalcet
Non-Proprietary Name
Cinacalcet
Substance Name
Cinacalcet Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CINACALCET HYDROCHLORIDE 30 mg/1
Pharmacologic Class
Usage Information
Cinacalcet hydrochloride tablets treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range [see Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
Strides Pharma Science Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA209226
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-16-2019
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 64380-883-04 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Cinacalcet, a human prescription drug labeled by Strides Pharma Science Limited. This tablet, film coated is formulated for oral use and contains cinacalcet 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 Strides Pharma Science Limited on July 16, 2019. The current certification is valid through December 31, 2027.

How is this Strides Pharma Science Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64380088304. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
64380-883-04
11-Digit CMS (5-4-2)
64380-0883-04

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