NDC 11994-001

Cardiolite

Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate

Cardiolite is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Lantheus Medical Imaging, Inc.. The primary component is Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate.

• Product ID: 11994-001_c33bb285-f025-4042-8179-4bdfdd2c43fc
• NDC: 11994-001
• Product Type: Human Prescription Drug
• Proprietary Name: Cardiolite
• Generic Name: Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1990-12-20
• Marketing Category: NDA / NDA
• Application Number: NDA019785
• Labeler Name: Lantheus Medical Imaging, Inc.
• Substance Name: TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
• Active Ingredient Strength: 1 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 11994-001-00

5 mL in 1 SYRINGE (11994-001-00)

• Marketing Start Date: 1990-12-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 11994-001-00 [11994000100]

Cardiolite INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019785
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-12-20

NDC 11994-001-20 [11994000120]

Cardiolite INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019785
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-02-28

NDC 11994-001-52 [11994000152]

Cardiolite INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019785
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-12-20

NDC 11994-001-55 [11994000155]

Cardiolite INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019785
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-12-20

Drug Details

Active Ingredients

Ingredient	Strength
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	1 mg/mL

OpenFDA Data

• SPL SET ID: 49662def-2fb9-47b2-8467-ca56f6006167
• Manufacturer:
  • Lantheus Medical Imaging, Inc.
• UNII:
  • N6OU7HJ70P

NDC Crossover Matching brand name "Cardiolite" or generic name "Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate"

NDC	Brand Name	Generic Name
11994-001	Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE
11994-003	Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE