VOXZOGO 1.2mg

Orange BookSPL

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

Identification

ManufacturerBioMarin Pharmaceutical Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6813518193
1 KIT in 1 CARTON (68135-181-93) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-130-92) / .6 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-158-17)

Annotations

Orange Book

N214938

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "228e8560-04a4-4bb1-a81f-29531a9e4d27": {
      "match": "brand_token",
      "title": "VOXZOGO 0.4MG (VOSORITIDE) KIT VOXZOGO 0.56MG (VOSORITIDE) KIT VOXZOGO 1.2MG (VOSORITIDE) KIT [BIOMARIN PHARMACEUTICAL INC.]",
      "spl_version": "16",
      "published_date": "2025-11-26"
    }
  },
  "productid": "68135-181_6100caa6-4951-4773-b80c-6be0c04efd24",
  "productndc": "68135-181",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214938",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4MG/VIAL",
        "product_no": "001",
        "approval_date": "Nov 19, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.56MG/VIAL",
        "product_no": "002",
        "approval_date": "Nov 19, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.2MG/VIAL",
        "product_no": "003",
        "approval_date": "Nov 19, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "VOXZOGO 1.2mg",
  "active_ingred_unit": null,
  "application_number": "NDA214938",
  "marketing_category": "NDA",
  "nonproprietary_name": "vosoritide",
  "start_marketing_date": "20211119",
  "active_numerator_strength": null
}

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