Zilretta

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPacira Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6525000301
1 KIT in 1 CARTON (65250-003-01) * 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)

Annotations

Orange Book

N208845

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRA-ARTICULAR",
  "spl_meta": {
    "cd5c4673-21f2-4126-9556-da847b3a228b": {
      "match": "brand_token",
      "title": "ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION) KIT [PACIRA PHARMACEUTICALS, INC.]",
      "spl_version": "6",
      "published_date": "2026-04-06"
    }
  },
  "productid": "65250-003_7d477c22-27b0-4c00-a5c3-d9dbb2d7374a",
  "productndc": "65250-003",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208845",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "32MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 6, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Zilretta",
  "active_ingred_unit": null,
  "application_number": "NDA208845",
  "marketing_category": "NDA",
  "nonproprietary_name": "triamcinolone acetonide extended-release injectable suspension",
  "start_marketing_date": "20171006",
  "active_numerator_strength": null
}

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