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 · 9

ndc11
5041932511
2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
5041932512
2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
ndc11
5041932513
2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE
ndc11
5041932527
5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASS
ndc11
5041932528
5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASS
ndc11
5041932529
5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASS
ndc11
5041932537
15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
ndc11
5041932572
10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSE
ndc11
5041932575
5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASS

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_67702ed5-ea44-4ed0-b65a-1d2a550ed3db",
  "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"
}

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