Gadavist

Orange BookUNIISPLATC V08CA09

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

Identification

ManufacturerBayer HealthCare Pharmaceuticals Inc.

CountryUS (United States)

ATC codeV08CA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5041932518
2 CARTON in 1 BOX (50419-325-18) / 5 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS
ndc11
5041932519
10 BOTTLE, GLASS in 1 BOX (50419-325-19) / 65 mL in 1 BOTTLE, GLASS
ndc11
5041932573
30 mL in 1 BOTTLE, GLASS (50419-325-73)
ndc11
5041932574
65 mL in 1 BOTTLE, GLASS (50419-325-74)

Annotations

UNII (FDA Substance ID)

1BJ477IO2L

GADOBUTROL

RxCUI 84990

Orange Book

N201277

APAPAPAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1BJ477IO2L",
    "rxcui": "84990",
    "inchikey": "ZPDFIIGFYAHNSK-CTHHTMFSSA-K;ZPDFIIGFYAHNSK-YYLIZZNMSA-K",
    "display_name": "GADOBUTROL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "bd28560f-de4d-4140-874e-31df823f4dbb": {
      "match": "brand_token",
      "title": "GADAVIST (GADOBUTROL) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
      "spl_version": "23",
      "published_date": "2026-05-28"
    }
  },
  "productid": "50419-325_8ff60f35-0672-462a-b5d8-c2fd9e2a4566",
  "productndc": "50419-325",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "201277",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "4.5354GM/7.5ML (604.72MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 14, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "6.0472GM/10ML (604.72MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 14, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "9.0708GM/15ML (604.72MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 14, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "18.1416GM/30ML (604.72MG/ML)",
        "product_no": "004",
        "approval_date": "Mar 14, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "39.3068GM/65ML (604.72MG/ML)",
        "product_no": "005",
        "approval_date": "Mar 14, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1.20944GM/2ML (604.72MG/ML)",
        "product_no": "006",
        "approval_date": "Dec 18, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GADOBUTROL",
  "proprietary_name": "Gadavist",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA201277",
  "marketing_category": "NDA",
  "nonproprietary_name": "gadobutrol",
  "start_marketing_date": "20110314",
  "active_numerator_strength": "604.72"
}

Related drugs

Other records sharing ATC code V08CA09.

Access this data programmatically

Query Gadavist 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