Giapreza

Orange BookUNIISPLATC C01CX09

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

Identification

ManufacturerLa Jolla Pharmaceutical Company

CountryUS (United States)

ATC codeC01CX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6854700501
1 VIAL, SINGLE-DOSE in 1 CARTON (68547-005-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

M089EFU921

ANGIOTENSIN II

RxCUI 1999003

Orange Book

N209360

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "M089EFU921",
    "rxcui": "1999003",
    "inchikey": null,
    "display_name": "ANGIOTENSIN II",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "c265d69a-3efe-4107-9a9e-e6fd3d531c48": {
      "match": "brand_token",
      "title": "GIAPREZA (ANGIOTENSIN II) INJECTION [LA JOLLA PHARMACEUTICAL COMPANY]",
      "spl_version": "17",
      "published_date": "2024-11-27"
    }
  },
  "productid": "68547-005_49438c9b-3fce-4f3b-b878-18a17bc62b2e",
  "productndc": "68547-005",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209360",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 21, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Dec 21, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Dec 23, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ANGIOTENSIN II",
  "proprietary_name": "Giapreza",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209360",
  "marketing_category": "NDA",
  "nonproprietary_name": "angiotensin II",
  "start_marketing_date": "20220915",
  "active_numerator_strength": ".5"
}

Related drugs

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