kit for the preparation of technetium tc 99m pentetate

Generic: kit for the preparation of technetium tc 99m pentetate

Labeler: curium us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name kit for the preparation of technetium tc 99m pentetate
Generic Name kit for the preparation of technetium tc 99m pentetate
Labeler curium us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS RESPIRATORY (INHALATION)
Active Ingredients

pentetic acid 20 mg/mL

Manufacturer
Curium US LLC

Identifiers & Regulatory

Product NDC 69945-314
Product ID 69945-314_3153807a-9849-8e8b-e063-6294a90a7c34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215146
Listing Expiration 2026-12-31
Marketing Start 2025-04-08

Pharmacologic Class

Established (EPC)
lead chelator [epc]
Mechanism of Action
lead chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69945314
Hyphenated Format 69945-314

Supplemental Identifiers

UNII
7A314HQM0I
NUI
N0000175962 N0000175963

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 kit for the preparation of technetium tc 99m pentetate (source: ndc)
Generic Name kit for the preparation of technetium tc 99m pentetate (source: ndc)
Application Number ANDA215146 (source: ndc)
Routes
INTRAVENOUS RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01)
  • 30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01)
source: ndc

Packages (2)

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

Ingredients (1)

pentetic acid (20 mg/mL)

Linked Drug Pages (1)

Kit for the Preparation of Technetium Tc 99m Pentetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "RESPIRATORY (INHALATION)"], "spl_id": "3153807a-9849-8e8b-e063-6294a90a7c34", "openfda": {"nui": ["N0000175962", "N0000175963"], "unii": ["7A314HQM0I"], "spl_set_id": ["59b3b7d5-ff69-4642-971e-99026d9dce89"], "pharm_class_epc": ["Lead Chelator [EPC]"], "pharm_class_moa": ["Lead Chelating Activity [MoA]"], "manufacturer_name": ["Curium US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 KIT (69945-314-05)  / 10 mL in 1 VIAL (69945-314-01)", "package_ndc": "69945-314-05", "marketing_start_date": "20250408"}, {"sample": false, "description": "30 VIAL in 1 CARTON (69945-314-30)  / 10 mL in 1 VIAL (69945-314-01)", "package_ndc": "69945-314-30", "marketing_start_date": "20250408"}], "brand_name": "Kit for the Preparation of Technetium Tc 99m Pentetate", "product_id": "69945-314_3153807a-9849-8e8b-e063-6294a90a7c34", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lead Chelating Activity [MoA]", "Lead Chelator [EPC]"], "product_ndc": "69945-314", "generic_name": "kit for the preparation of technetium tc 99m pentetate", "labeler_name": "Curium US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kit for the Preparation of Technetium Tc 99m Pentetate", "active_ingredients": [{"name": "PENTETIC ACID", "strength": "20 mg/mL"}], "application_number": "ANDA215146", "marketing_category": "ANDA", "marketing_start_date": "20250408", "listing_expiration_date": "20261231"}