LUTRATE DEPOT

Orange BookSPL

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

Identification

ManufacturerAvyxa Pharma, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8383113401
1 KIT in 1 CARTON (83831-134-01) * 2 mL in 1 VIAL, SINGLE-DOSE (83831-150-22) * 2 mL in 1 SYRINGE (83831-135-02)

Annotations

Orange Book

N205054

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "3a6d1373-17d9-4289-b62f-d299ffe55831": {
      "match": "brand_token",
      "title": "LUTRATE DEPOT (LEUPROLIDE ACETATE) KIT [AVYXA PHARMA, LLC]",
      "spl_version": "2",
      "published_date": "2025-06-27"
    }
  },
  "productid": "83831-134_d4332d30-8a83-4118-88bb-3c49851837b6",
  "productndc": "83831-134",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205054",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "22.5MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 28, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LUTRATE DEPOT",
  "active_ingred_unit": null,
  "application_number": "NDA205054",
  "marketing_category": "NDA",
  "nonproprietary_name": "leuprolide acetate",
  "start_marketing_date": "20250326",
  "active_numerator_strength": null
}

Access this data programmatically

Query LUTRATE DEPOT and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs