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United States · US · US:11994-091_ffbbca75-06da-47fc-bc12-ceefdf308162

TechneLite

In shortageOrange BookUNIISPLATC V09FX01

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

Identification

ManufacturerLantheus Medical Imaging, Inc.
CountryUS (United States)
ATC codeV09FX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 14

  • ndc11
    1199409101
    1 VIAL in 1 CARTON (11994-091-01) / 12 mL in 1 VIAL
  • ndc11
    1199409103
    1 VIAL in 1 CARTON (11994-091-03) / 16 mL in 1 VIAL
  • ndc11
    1199409104
    1 VIAL in 1 CARTON (11994-091-04) / 18 mL in 1 VIAL
  • ndc11
    1199409105
    1 VIAL in 1 CARTON (11994-091-05) / 20 mL in 1 VIAL
  • ndc11
    1199409106
    1 VIAL in 1 CARTON (11994-091-06) / 24 mL in 1 VIAL
  • ndc11
    1199409107
    1 VIAL in 1 CARTON (11994-091-07) / 30 mL in 1 VIAL
  • ndc11
    1199409109
    1 VIAL in 1 CARTON (11994-091-09) / 40 mL in 1 VIAL
  • ndc11
    1199409110
    1 VIAL in 1 CARTON (11994-091-10) / 50 mL in 1 VIAL
  • ndc11
    1199409111
    1 VIAL in 1 CARTON (11994-091-11) / 60 mL in 1 VIAL
  • ndc11
    1199409112
    1 VIAL in 1 CARTON (11994-091-12) / 72 mL in 1 VIAL
  • ndc11
    1199409113
    1 VIAL in 1 CARTON (11994-091-13) / 80 mL in 1 VIAL
  • ndc11
    1199409136
    1 VIAL in 1 CARTON (11994-091-36) / 4 mL in 1 VIAL
  • ndc11
    1199409173
    1 VIAL in 1 CARTON (11994-091-73) / 8 mL in 1 VIAL
  • ndc11
    1199409192
    1 VIAL in 1 CARTON (11994-091-92) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
A0730CX801
TECHNETIUM TC-99M SODIUM PERTECHNETATE
RxCUI 10349
Orange Book
N017771
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Technetium TC-99M Pyrophosphate Kit Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "A0730CX801",
    "rxcui": "10349",
    "inchikey": "MKADDTFVKFMZGF-PUQAOBSFSA-N",
    "display_name": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4": {
      "match": "brand_token",
      "title": "TECHNELITE (TECHNETIUM TC99M GENERATOR) INJECTION, SOLUTION [LANTHEUS MEDICAL IMAGING, INC.]",
      "spl_version": "17",
      "published_date": "2024-11-06"
    }
  },
  "productid": "11994-091_ffbbca75-06da-47fc-bc12-ceefdf308162",
  "productndc": "11994-091",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017771",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.0083-2.7 CI/GENERATOR",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1-20 CI/GENERATOR",
        "product_no": "002",
        "approval_date": "Feb 12, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TECHNETIUM TC-99M SODIUM PERTECHNETATE",
  "shortage_reason": "Technetium TC-99M Pyrophosphate Kit Injection",
  "shortage_status": "current",
  "proprietary_name": "TechneLite",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA017771",
  "marketing_category": "NDA",
  "nonproprietary_name": "Technetium Tc99m Generator",
  "start_marketing_date": "19751101",
  "active_numerator_strength": "250"
}

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