NDC 71258-015

Azedra

Iobenguane I-131

Azedra is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Progenics Pharmaceuticals, Inc.. The primary component is Iobenguane I-131.

• Product ID: 71258-015_20fd0c7f-7325-44a2-9faa-37874de7576e
• NDC: 71258-015
• Product Type: Human Prescription Drug
• Proprietary Name: Azedra
• Generic Name: Iobenguane I-131
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-07-30
• Marketing Category: NDA / NDA
• Application Number: NDA209607
• Labeler Name: Progenics Pharmaceuticals, Inc.
• Substance Name: IOBENGUANE I-131
• Active Ingredient Strength: 15 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 71258-015-02

1 CONTAINER in 1 BOX, UNIT-DOSE (71258-015-02) > 1 VIAL, GLASS in 1 CONTAINER > 2 mL in 1 VIAL, GLASS

• Marketing Start Date: 2018-07-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71258-015-02 [71258001502]

Azedra INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209607
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-30

NDC 71258-015-22 [71258001522]

Azedra INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209607
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-30

Drug Details

Active Ingredients

Ingredient	Strength
IOBENGUANE I-131	15 mCi/mL

OpenFDA Data

• SPL SET ID: 3423ac0f-9585-4abf-a8ba-a5123a8277ee
• Manufacturer:
  • Progenics Pharmaceuticals, Inc.
• UNII:
  • Q461L7AK4R
• RxNorm Concept Unique ID - RxCUI:
  • 2053286
  • 2053296
  • 2053297
  • 2053291

Pharmacological Class

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