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United States · US · US:65174-288_ea90e623-af26-4014-a0c3-3fe5d753a5e6

DRAXIMAGE DTPA

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

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
    6517428830
    30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30)

Annotations

UNII (FDA Substance ID)
7A314HQM0I
PENTETIC ACID
RxCUI 3690
Orange Book
N018511
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7A314HQM0I",
    "rxcui": "3690",
    "inchikey": "QPCDCPDFJACHGM-UHFFFAOYSA-N",
    "display_name": "PENTETIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; RESPIRATORY (INHALATION)",
  "spl_meta": {
    "bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b": {
      "match": "brand_token",
      "title": "DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC]",
      "spl_version": "11",
      "published_date": "2024-02-14"
    }
  },
  "productid": "65174-288_ea90e623-af26-4014-a0c3-3fe5d753a5e6",
  "productndc": "65174-288",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "018511",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Dec 29, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENTETIC ACID",
  "proprietary_name": "DRAXIMAGE DTPA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018511",
  "marketing_category": "NDA",
  "nonproprietary_name": "Kit for the preparation of Technetium Tc 99m Pentetate",
  "start_marketing_date": "19891229",
  "active_numerator_strength": "20"
}

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