kit for the preparation of technetium tc 99m sulfur colloid

Generic: technetium tc 99m sulfur colloid kit

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

Drug Facts

Product Profile

Brand Name kit for the preparation of technetium tc 99m sulfur colloid
Generic Name technetium tc 99m sulfur colloid kit
Labeler jubilant draximage inc., dba jubilant radiopharma
Dosage Form KIT
Manufacturer
Jubilant DraxImage Inc., dba Jubilant Radiopharma

Identifiers & Regulatory

Product NDC 65174-179
Product ID 65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213516
Listing Expiration 2026-12-31
Marketing Start 2023-12-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65174179
Hyphenated Format 65174-179

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 sulfur colloid (source: ndc)
Generic Name technetium tc 99m sulfur colloid kit (source: ndc)
Application Number ANDA213516 (source: ndc)

Resolved Composition

Strengths
  • 10 ml
  • 2 mg
  • 2.3 mg
  • 18.1 mg
  • 1.8 ml
  • 24.6 mg/ml
  • 7.9 mg/ml
source: label
Packaging
  • 1 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01)
source: ndc

Packages (1)

65174-179-01 1 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "92a1bc37-cc23-4498-ad61-29347c3876dc", "openfda": {"spl_set_id": ["f756e00e-0acd-4c5d-97f8-ed57f23a2393"], "manufacturer_name": ["Jubilant DraxImage Inc., dba Jubilant Radiopharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE (65174-179-01)  *  3 mL in 1 VIAL (65174-046-01)  *  3 mL in 1 VIAL (65174-047-01)  *  10 mL in 1 VIAL (65174-131-01)", "package_ndc": "65174-179-01", "marketing_start_date": "20231204"}], "brand_name": "Kit for the Preparation of Technetium Tc 99m Sulfur Colloid", "product_id": "65174-179_92a1bc37-cc23-4498-ad61-29347c3876dc", "dosage_form": "KIT", "product_ndc": "65174-179", "generic_name": "Technetium Tc 99m Sulfur Colloid Kit", "labeler_name": "Jubilant DraxImage Inc., dba Jubilant Radiopharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kit for the Preparation of Technetium Tc 99m Sulfur Colloid", "application_number": "ANDA213516", "marketing_category": "ANDA", "marketing_start_date": "20231204", "listing_expiration_date": "20261231"}