Kit for the Preparation of Technetium Tc 99m Pentetate

Orange BookUNIISPL

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

Identification

ManufacturerCurium US LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6994531405
5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01)
ndc11
6994531430
30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01)

Annotations

UNII (FDA Substance ID)

7A314HQM0I

PENTETIC ACID

RxCUI 3690

Orange Book

A215146

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": {
    "54608807-4df6-49ba-b065-59a19ef224c4": {
      "match": "brand_token",
      "title": "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC]",
      "spl_version": "5",
      "published_date": "2025-09-10"
    }
  },
  "productid": "69945-314_3153807a-9849-8e8b-e063-6294a90a7c34",
  "productndc": "69945-314",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "215146",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Mar 26, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENTETIC ACID",
  "proprietary_name": "Kit for the Preparation of Technetium Tc 99m Pentetate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215146",
  "marketing_category": "ANDA",
  "nonproprietary_name": "kit for the preparation of technetium tc 99m pentetate",
  "start_marketing_date": "20250408",
  "active_numerator_strength": "20"
}

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