TRIPTODUR

Orange BookSPL

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2433815020
1 KIT in 1 CARTON (24338-150-20) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS

Annotations

Orange Book

N208956

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "f41380e7-b830-432d-a5f5-a872932f107e": {
      "match": "brand_token",
      "title": "TRIPTODUR (TRIPTORELIN) KIT [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "16",
      "published_date": "2025-09-29"
    }
  },
  "productid": "24338-150_1c06d8b5-edbc-4de7-a423-7588069d3c38",
  "productndc": "24338-150",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208956",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 22.5MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jun 29, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "TRIPTODUR",
  "active_ingred_unit": null,
  "application_number": "NDA208956",
  "marketing_category": "NDA",
  "nonproprietary_name": "triptorelin",
  "start_marketing_date": "20170908",
  "active_numerator_strength": null
}

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