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  4. NDC Product Code: 65250-003 Zilretta

NDC 65250-003 Zilretta

Triamcinolone Acetonide Extended-release Injectable Suspension Kit Intra-articular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 65250-003?
  4. Zilretta Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
65250-003
Proprietary Name:
Zilretta
Non-Proprietary Name: [1]
Triamcinolone Acetonide Extended-release Injectable Suspension
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Intra-articular - Administration within a joint.
    • Labeler Name: [5]
    Pacira Pharmaceuticals, Inc.
    Labeler Code:
    65250
    Product Label ID:
    cd5c4673-21f2-4126-9556-da847b3a228b
    FDA Application Number: [6]
    NDA208845
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    10-06-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 65250-003?

    The NDC code 65250-003 is assigned by the FDA to the product Zilretta which is a human prescription drug product labeled by Pacira Pharmaceuticals, Inc.. The generic name of Zilretta is triamcinolone acetonide extended-release injectable suspension. The product's dosage form is kit and is administered via intra-articular form. The product is distributed in a single package with assigned NDC code 65250-003-01 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). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Zilretta?

    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.

    Which are Zilretta UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • TRIAMCINOLONE ACETONIDE (UNII: F446C597KA)
    • TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Zilretta?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".