NDC 17156-210

DaTscan

Ioflupane I-123

DaTscan is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Medi-physics Inc. Dba Ge Healthcare.. The primary component is Ioflupane I-123.

• Product ID: 17156-210_2db95ab5-0bda-4925-84a6-ee1b1c1fa8d0
• NDC: 17156-210
• Product Type: Human Prescription Drug
• Proprietary Name: DaTscan
• Generic Name: Ioflupane I-123
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA022454
• Labeler Name: Medi-Physics Inc. dba GE Healthcare.
• Substance Name: IOFLUPANE I-123
• Active Ingredient Strength: 2 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 17156-210-01

1 VIAL, GLASS in 1 CONTAINER (17156-210-01) > 2.5 mL in 1 VIAL, GLASS

• Marketing Start Date: 2011-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17156-210-01 [17156021001]

DaTscan INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA022454
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-01

Drug Details

Active Ingredients

Ingredient	Strength
IOFLUPANE I-123	2 mCi/mL

OpenFDA Data

• SPL SET ID: ef7804d7-c691-495b-8aaf-5bc54fd5d9f6
• Manufacturer:
  • Medi-Physics Inc. dba GE Healthcare.
• UNII:
  • 3MM99T8R5Q

Pharmacological Class

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

NDC Crossover Matching brand name "DaTscan" or generic name "Ioflupane I-123"

NDC	Brand Name	Generic Name
17156-210	DaTscan	Ioflupane I-123
69945-166	Ioflupane I 123	IOFLUPANE I-123