NDC 11994-016

Quadramet

Samarium Sm 153 Lexidronam

Quadramet is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Lantheus Medical Imaging, Inc.. The primary component is Samarium Sm-153 Lexidronam Pentasodium.

• Product ID: 11994-016_3f73e214-cad4-4b6d-b1ed-66f1777b57f4
• NDC: 11994-016
• Product Type: Human Prescription Drug
• Proprietary Name: Quadramet
• Generic Name: Samarium Sm 153 Lexidronam
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1997-05-19
• Marketing Category: NDA / NDA
• Application Number: NDA020570
• Labeler Name: Lantheus Medical Imaging, Inc.
• Substance Name: SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
• Active Ingredient Strength: 50 mCi/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 11994-016-01

3 mL in 1 VIAL, SINGLE-DOSE (11994-016-01)

• Marketing Start Date: 1997-05-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11994-016-01 [11994001601]

Quadramet INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020570
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-05-19

Drug Details

Active Ingredients

Ingredient	Strength
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM	50 mCi/mL

OpenFDA Data

• SPL SET ID: 61e84808-0999-4923-910c-2a480d5f971a
• Manufacturer:
  • Lantheus Medical Imaging, Inc.
• UNII:
  • 7389YR3OOV
• RxNorm Concept Unique ID - RxCUI:
  • 797657
  • 797659