Fensolvi

Orange BookSPL

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

Identification

ManufacturerTOLMAR Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6293515350
1 KIT in 1 CARTON (62935-153-50) * .375 mL in 1 SYRINGE (62935-154-50) * .375 mL in 1 SYRINGE (62935-155-40)

Annotations

Orange Book

N213150

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "2c311700-edf4-4f2a-a468-9875489a6cc7": {
      "match": "brand_token",
      "title": "FENSOLVI (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.]",
      "spl_version": "12",
      "published_date": "2025-09-29"
    }
  },
  "productid": "62935-153_eeda0531-099b-4b55-b287-8c534c3bb5f0",
  "productndc": "62935-153",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "213150",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "45MG",
        "product_no": "001",
        "approval_date": "May 1, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Fensolvi",
  "active_ingred_unit": null,
  "application_number": "NDA213150",
  "marketing_category": "NDA",
  "nonproprietary_name": "Leuprolide Acetate",
  "start_marketing_date": "20200603",
  "active_numerator_strength": null
}

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