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United States · US · US:45567-0060_3010b45e-eed1-a5d0-e063-6294a90a40cf

Kit for the Preparation of Technetium Tc99m Pyrophosphate

In shortageOrange BookUNIISPLATC V09BA03

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeV09BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4556700601
    5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    4556700602
    30 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
5L76I61H2B
TECHNETIUM TC-99M PYROPHOSPHATE
RxCUI 1488368
Orange Book
N019039
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Technetium TC-99M Pyrophosphate Kit Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "5L76I61H2B",
    "rxcui": "1488368",
    "inchikey": "XKOTYHZFBGQINA-IEOVAKBOSA-J",
    "display_name": "TECHNETIUM TC-99M PYROPHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "45567-0060_3010b45e-eed1-a5d0-e063-6294a90a40cf",
  "productndc": "45567-0060",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019039",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Jun 30, 1987"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TECHNETIUM TC-99M PYROPHOSPHATE",
  "shortage_reason": "Technetium TC-99M Pyrophosphate Kit Injection",
  "shortage_status": "current",
  "proprietary_name": "Kit for the Preparation of Technetium Tc99m Pyrophosphate",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA019039",
  "marketing_category": "NDA",
  "nonproprietary_name": "technetium tc99m pyrophosphate",
  "start_marketing_date": "19870630",
  "active_numerator_strength": "12"
}

Related drugs

Other records sharing ATC code V09BA03.

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