draximage dtpa

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

Labeler: jubilant draximage inc., dba jubilant radiopharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name draximage dtpa
Generic Name kit for the preparation of technetium tc 99m pentetate
Labeler jubilant draximage inc., dba jubilant radiopharma
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS RESPIRATORY (INHALATION)
Active Ingredients

pentetic acid 20 mg/1

Manufacturer
Jubilant DraxImage Inc., dba Jubilant Radiopharma

Identifiers & Regulatory

Product NDC 65174-288
Product ID 65174-288_ea90e623-af26-4014-a0c3-3fe5d753a5e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018511
Listing Expiration 2026-12-31
Marketing Start 1989-12-29

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 65174288
Hyphenated Format 65174-288

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 draximage dtpa (source: ndc)
Generic Name kit for the preparation of technetium tc 99m pentetate (source: ndc)
Application Number NDA018511 (source: ndc)
Routes
INTRAVENOUS RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30)
source: ndc

Packages (1)

65174-288-30 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30)

Ingredients (1)

pentetic acid (20 mg/1)

Linked Drug Pages (1)

DRAXIMAGE DTPA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "RESPIRATORY (INHALATION)"], "spl_id": "ea90e623-af26-4014-a0c3-3fe5d753a5e6", "openfda": {"nui": ["N0000175962", "N0000175963"], "unii": ["7A314HQM0I"], "spl_set_id": ["becdab53-f7a7-7280-6930-21f3a61b99e7"], "pharm_class_epc": ["Lead Chelator [EPC]"], "pharm_class_moa": ["Lead Chelating Activity [MoA]"], "manufacturer_name": ["Jubilant DraxImage Inc., dba Jubilant Radiopharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30)", "package_ndc": "65174-288-30", "marketing_start_date": "19891229"}], "brand_name": "DRAXIMAGE DTPA", "product_id": "65174-288_ea90e623-af26-4014-a0c3-3fe5d753a5e6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lead Chelating Activity [MoA]", "Lead Chelator [EPC]"], "product_ndc": "65174-288", "generic_name": "Kit for the preparation of Technetium Tc 99m Pentetate", "labeler_name": "Jubilant DraxImage Inc., dba Jubilant Radiopharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DRAXIMAGE DTPA", "active_ingredients": [{"name": "PENTETIC ACID", "strength": "20 mg/1"}], "application_number": "NDA018511", "marketing_category": "NDA", "marketing_start_date": "19891229", "listing_expiration_date": "20261231"}