ZELSUVMI

Orange BookSPL

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

Identification

ManufacturerLNHC, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8378710331
1 KIT in 1 KIT (83787-103-31) * 1 TUBE in 1 CARTON / 17 g in 1 TUBE * 1 TUBE in 1 CARTON / 14 g in 1 TUBE (83787-113-14)

Annotations

Orange Book

N217424

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "76b17622-bdb9-41ea-b962-c2acc0df71f7": {
      "match": "brand_token",
      "title": "ZELSUVMI (BERDAZIMER) KIT [LNHC, INC.]",
      "spl_version": "3",
      "published_date": "2025-07-10"
    }
  },
  "productid": "83787-103_0af12ae7-bb37-4319-94d1-8074b39d4e1b",
  "productndc": "83787-103",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "217424",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10.3% BASE",
        "product_no": "001",
        "approval_date": "Jan 5, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ZELSUVMI",
  "active_ingred_unit": null,
  "application_number": "NDA217424",
  "marketing_category": "NDA",
  "nonproprietary_name": "berdazimer",
  "start_marketing_date": "20250404",
  "active_numerator_strength": null
}

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