ruby-fill

Generic: rubidium rb 82

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

Drug Facts

Product Profile

Brand Name ruby-fill
Generic Name rubidium rb 82
Labeler jubilant draximage inc., dba jubilant radiopharma
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

rubidium chloride rb-82 100 mCi/1

Manufacturer
Jubilant DraxImage Inc., dba Jubilant Radiopharma

Identifiers & Regulatory

Product NDC 65174-021
Product ID 65174-021_efb00947-c7d1-4fc8-8ca0-24d80952b7ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202153
Listing Expiration 2026-12-31
Marketing Start 2016-09-30

Pharmacologic Class

Classes
radioactive diagnostic agent [epc] radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65174021
Hyphenated Format 65174-021

Supplemental Identifiers

UNII
F0Z746KRKQ

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 ruby-fill (source: ndc)
Generic Name rubidium rb 82 (source: ndc)
Application Number NDA202153 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mCi/1
source: ndc
Packaging
  • 1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10)
source: ndc

Packages (1)

65174-021-10 1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10)

Ingredients (1)

rubidium chloride rb-82 (100 mCi/1)

Linked Drug Pages (1)

RUBY-FILL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "efb00947-c7d1-4fc8-8ca0-24d80952b7ef", "openfda": {"unii": ["F0Z746KRKQ"], "spl_set_id": ["b3c0cc0c-2f4b-4e08-8a84-3cb77473c2e8"], "manufacturer_name": ["Jubilant DraxImage Inc., dba Jubilant Radiopharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10)", "package_ndc": "65174-021-10", "marketing_start_date": "20160930"}], "brand_name": "RUBY-FILL", "product_id": "65174-021_efb00947-c7d1-4fc8-8ca0-24d80952b7ef", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "65174-021", "generic_name": "Rubidium Rb 82", "labeler_name": "Jubilant DraxImage Inc., dba Jubilant Radiopharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RUBY-FILL", "active_ingredients": [{"name": "RUBIDIUM CHLORIDE RB-82", "strength": "100 mCi/1"}], "application_number": "NDA202153", "marketing_category": "NDA", "marketing_start_date": "20160930", "listing_expiration_date": "20261231"}