Zilretta Kit
NDC Package 65250-003-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Zilretta (triamcinolone acetonide extended-release injectable suspension) kits is a medication used to treat knee pain in people with a certain type of arthritis (osteoarthritis). This formulation utilizes a kit delivery system. Marketed by Pacira Pharmaceuticals, Inc., this product is identified by NDC 65250-003 and is authorized under FDA application NDA208845.

Identification & Billing

NDC Package Code
65250-003-01
Package Description
1 KIT in 1 CARTON * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01)
Product Code
11-Digit Billing Format
65250000301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zilretta
Non-Proprietary Name
Triamcinolone Acetonide Extended-release Injectable Suspension
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intra-articular - Administration within a joint.
Usage Information
This medication is used to treat knee pain in people with a certain type of arthritis (osteoarthritis). It works by reducing your body's immune response. Triamcinolone belongs to a class of drugs known as corticosteroids. It helps to reduce pain and swelling in the knee.

Regulatory & Marketing

Labeler Name
Pacira Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208845
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-06-2017
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Source: PDAC
INJECTION, TRIAMCINOLONE ACETONIDE, PRESERVATIVE-FREE, EXTENDED-RELEASE, MICROSPHERE FORMULATION, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 65250-003-01 identifies a specific commercial package of 1 kit in 1 carton * 1 injection, powder, for suspension, extended release in 1 vial, single-dose (65250-001-01) * 1 injection, solution in 1 vial, single-dose (65250-002-01) of Zilretta, a human prescription drug labeled by Pacira Pharmaceuticals, Inc.. This kit is formulated for intra-articular use and contains 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 Pacira Pharmaceuticals, Inc. on October 06, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat knee pain in people with a certain type of arthritis (osteoarthritis). It works by reducing your body's immune response. Triamcinolone belongs to a class of drugs known as corticosteroids. It helps to reduce pain and swelling in the knee.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65250000301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
65250-003-01
11-Digit CMS (5-4-2)
65250-0003-01

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