technelite

Generic: technetium tc99m generator

Labeler: lantheus medical imaging, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name technelite
Generic Name technetium tc99m generator
Labeler lantheus medical imaging, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

technetium tc-99m sodium pertechnetate 250 mCi/mL

Manufacturer
Lantheus Medical Imaging, Inc.

Identifiers & Regulatory

Product NDC 11994-091
Product ID 11994-091_ffbbca75-06da-47fc-bc12-ceefdf308162
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017771
Listing Expiration 2026-12-31
Marketing Start 1975-11-01

Pharmacologic Class

Established (EPC)
radioactive diagnostic agent [epc]
Mechanism of Action
radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11994091
Hyphenated Format 11994-091

Supplemental Identifiers

UNII
A0730CX801
NUI
N0000177914 N0000000205

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name technelite (source: ndc)
Generic Name technetium tc99m generator (source: ndc)
Application Number NDA017771 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mCi/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (11994-091-01) / 12 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-03) / 16 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-04) / 18 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-05) / 20 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-06) / 24 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-07) / 30 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-09) / 40 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-10) / 50 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-11) / 60 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-12) / 72 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-13) / 80 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-36) / 4 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-73) / 8 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (11994-091-92) / 10 mL in 1 VIAL
source: ndc

Packages (14)

11994-091-01 1 VIAL in 1 CARTON (11994-091-01) / 12 mL in 1 VIAL 11994-091-03 1 VIAL in 1 CARTON (11994-091-03) / 16 mL in 1 VIAL 11994-091-04 1 VIAL in 1 CARTON (11994-091-04) / 18 mL in 1 VIAL 11994-091-05 1 VIAL in 1 CARTON (11994-091-05) / 20 mL in 1 VIAL 11994-091-06 1 VIAL in 1 CARTON (11994-091-06) / 24 mL in 1 VIAL 11994-091-07 1 VIAL in 1 CARTON (11994-091-07) / 30 mL in 1 VIAL 11994-091-09 1 VIAL in 1 CARTON (11994-091-09) / 40 mL in 1 VIAL 11994-091-10 1 VIAL in 1 CARTON (11994-091-10) / 50 mL in 1 VIAL 11994-091-11 1 VIAL in 1 CARTON (11994-091-11) / 60 mL in 1 VIAL 11994-091-12 1 VIAL in 1 CARTON (11994-091-12) / 72 mL in 1 VIAL 11994-091-13 1 VIAL in 1 CARTON (11994-091-13) / 80 mL in 1 VIAL 11994-091-36 1 VIAL in 1 CARTON (11994-091-36) / 4 mL in 1 VIAL 11994-091-73 1 VIAL in 1 CARTON (11994-091-73) / 8 mL in 1 VIAL 11994-091-92 1 VIAL in 1 CARTON (11994-091-92) / 10 mL in 1 VIAL

Ingredients (1)

technetium tc-99m sodium pertechnetate (250 mCi/mL)

Linked Drug Pages (1)

TechneLite ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ffbbca75-06da-47fc-bc12-ceefdf308162", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["A0730CX801"], "spl_set_id": ["3ae14c6b-3daf-4dd1-bbdb-e990fe8100e4"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Lantheus Medical Imaging, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-01)  / 12 mL in 1 VIAL", "package_ndc": "11994-091-01", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-03)  / 16 mL in 1 VIAL", "package_ndc": "11994-091-03", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-04)  / 18 mL in 1 VIAL", "package_ndc": "11994-091-04", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-05)  / 20 mL in 1 VIAL", "package_ndc": "11994-091-05", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-06)  / 24 mL in 1 VIAL", "package_ndc": "11994-091-06", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-07)  / 30 mL in 1 VIAL", "package_ndc": "11994-091-07", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-09)  / 40 mL in 1 VIAL", "package_ndc": "11994-091-09", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-10)  / 50 mL in 1 VIAL", "package_ndc": "11994-091-10", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-11)  / 60 mL in 1 VIAL", "package_ndc": "11994-091-11", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-12)  / 72 mL in 1 VIAL", "package_ndc": "11994-091-12", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-13)  / 80 mL in 1 VIAL", "package_ndc": "11994-091-13", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-36)  / 4 mL in 1 VIAL", "package_ndc": "11994-091-36", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-73)  / 8 mL in 1 VIAL", "package_ndc": "11994-091-73", "marketing_start_date": "20100928"}, {"sample": false, "description": "1 VIAL in 1 CARTON (11994-091-92)  / 10 mL in 1 VIAL", "package_ndc": "11994-091-92", "marketing_start_date": "20100928"}], "brand_name": "TechneLite", "product_id": "11994-091_ffbbca75-06da-47fc-bc12-ceefdf308162", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "11994-091", "generic_name": "Technetium Tc99m Generator", "labeler_name": "Lantheus Medical Imaging, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TechneLite", "active_ingredients": [{"name": "TECHNETIUM TC-99M SODIUM PERTECHNETATE", "strength": "250 mCi/mL"}], "application_number": "NDA017771", "marketing_category": "NDA", "marketing_start_date": "19751101", "listing_expiration_date": "20261231"}