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 · 10

ndc11
0019133200
20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-00) / 100 mL in 1 SYRINGE, PLASTIC
ndc11
0019133206
25 BOTTLE, GLASS in 1 CARTON (0019-1332-06) / 50 mL in 1 BOTTLE, GLASS
ndc11
0019133211
12 BOTTLE, GLASS in 1 CARTON (0019-1332-11) / 100 mL in 1 BOTTLE, GLASS
ndc11
0019133216
12 BOTTLE, GLASS in 1 CARTON (0019-1332-16) / 150 mL in 1 BOTTLE, GLASS
ndc11
0019133221
12 BOTTLE, GLASS in 1 CARTON (0019-1332-21) / 200 mL in 1 BOTTLE, GLASS
ndc11
0019133275
20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-75) / 50 mL in 1 SYRINGE, PLASTIC
ndc11
0019133278
20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-78) / 50 mL in 1 SYRINGE, PLASTIC
ndc11
0019133283
20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-83) / 100 mL in 1 SYRINGE, PLASTIC
ndc11
0019133290
20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-90) / 100 mL in 1 SYRINGE, PLASTIC
ndc11
0019133291
20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-91) / 75 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)

N3RIB7X24K

IOVERSOL

RxCUI 27792

Orange Book

N019710

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": "0019-1332_1884aaeb-c174-4df7-a710-82d2b1869ad2",
  "productndc": "0019-1332",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019710",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "68%",
        "product_no": "001",
        "approval_date": "Dec 30, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "51%",
        "product_no": "002",
        "approval_date": "Dec 30, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "34%",
        "product_no": "003",
        "approval_date": "Dec 30, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "64%",
        "product_no": "004",
        "approval_date": "Jan 22, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "74%",
        "product_no": "005",
        "approval_date": "Jan 22, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOVERSOL",
  "proprietary_name": "Optiray",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019710",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ioversol",
  "start_marketing_date": "20120304",
  "active_numerator_strength": "636"
}

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