Optiray

Orange BookUNIISPLATC V08AB07

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

Identification

ManufacturerLiebel-Flarsheim Company LLC

CountryUS (United States)

ATC codeV08AB07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0019133365
6 BOTTLE, GLASS in 1 CARTON (0019-1333-65) / 500 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)

N3RIB7X24K

IOVERSOL

RxCUI 27792

Orange Book

N020923

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "N3RIB7X24K",
    "rxcui": "27792",
    "inchikey": "AMDBBAQNWSUWGN-UHFFFAOYSA-N",
    "display_name": "IOVERSOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTERIAL; INTRAVENOUS",
  "spl_meta": {
    "cd718d1c-f813-4114-a50d-c744ff7eb1bf": {
      "match": "brand_token",
      "title": "OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC]",
      "spl_version": "7",
      "published_date": "2025-12-31"
    }
  },
  "productid": "0019-1333_471b778f-d9cc-ff10-e063-6394a90a27c9",
  "productndc": "0019-1333",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020923",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "51%",
        "product_no": "001",
        "approval_date": "May 28, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "68%",
        "product_no": "002",
        "approval_date": "May 29, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "74%",
        "product_no": "003",
        "approval_date": "May 28, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "64%",
        "product_no": "004",
        "approval_date": "May 13, 1999"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOVERSOL",
  "proprietary_name": "Optiray",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020923",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ioversol",
  "start_marketing_date": "20201118",
  "active_numerator_strength": "741"
}

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