Technetium Tc 99m Medronate

Orange BookUNIISPL

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

Identification

ManufacturerJubilant DraxImage Inc., dba Jubilant Radiopharma

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6517466030
30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (65174-660-30)

Annotations

UNII (FDA Substance ID)

73OS0QIN3O

MEDRONIC ACID

RxCUI 1314368

Orange Book

N018035

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "73OS0QIN3O",
    "rxcui": "1314368",
    "inchikey": "MBKDYNNUVRNNRF-UHFFFAOYSA-N",
    "display_name": "MEDRONIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3c91d0d8-6cc5-834c-bda0-aa83a873b9fb": {
      "match": "brand_token",
      "title": "TECHNETIUM TC 99M MEDRONATE INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA]",
      "spl_version": "4",
      "published_date": "2025-06-13"
    }
  },
  "productid": "65174-660_71674538-1da8-436f-be11-7e964a2c5b05",
  "productndc": "65174-660",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "018035",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "N/A",
        "product_no": "002",
        "approval_date": "Feb 27, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEDRONIC ACID",
  "proprietary_name": "Technetium Tc 99m Medronate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018035",
  "marketing_category": "NDA",
  "nonproprietary_name": "Technetium Tc 99m Medronate",
  "start_marketing_date": "20040227",
  "active_numerator_strength": "25"
}

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