NDC 65174-125

RUBY-FILL

Rubidium Rb 82

RUBY-FILL is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Jubilant Draximage Inc.. The primary component is Rubidium Chloride Rb-82.

• Product ID: 65174-125_5d6cc9cc-7501-4861-ad1c-c3ad0574e812
• NDC: 65174-125
• Product Type: Human Prescription Drug
• Proprietary Name: RUBY-FILL
• Generic Name: Rubidium Rb 82
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-09-30
• Marketing Category: NDA / NDA
• Application Number: NDA202153
• Labeler Name: Jubilant DraxImage Inc.
• Substance Name: RUBIDIUM CHLORIDE RB-82
• Active Ingredient Strength: 100 mCi/1
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65174-125-01

1 INJECTION, SOLUTION in 1 CONTAINER (65174-125-01)

• Marketing Start Date: 2016-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65174-125-01 [65174012501]

RUBY-FILL INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA202153
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-30
• Marketing End Date: 2019-10-30

Drug Details

Active Ingredients

Ingredient	Strength
RUBIDIUM CHLORIDE RB-82	100 mCi/1

OpenFDA Data

• SPL SET ID: b3c0cc0c-2f4b-4e08-8a84-3cb77473c2e8
• Manufacturer:
  • Jubilant DraxImage Inc.
• UNII:
  • F0Z746KRKQ

Pharmacological Class

• Radioactive Diagnostic Agent [EPC]
• Radiopharmaceutical Activity [MoA]

NDC Crossover Matching brand name "RUBY-FILL" or generic name "Rubidium Rb 82"

NDC	Brand Name	Generic Name
65174-021	RUBY-FILL	Rubidium Rb 82
65174-125	RUBY-FILL	Rubidium Rb 82