AMBELVIST Solution for injection Ref.[116696] Active ingredients: Gadoquatrane

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

AMBELVIST (gadoquatrane) injection is a paramagnetic tetrameric macrocyclic gadolinium-based contrast agent for intravenous use.

The chemical name for gadoquatrane is tetragadolinium [4,10-bis(carboxylatomethyl)-7-{3,6,12,15-tetraoxo-16-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]-9,9-bis({[({2-[4,7,10-tris-(carboxylatomethyl)-1,4,7,10-tetraazacyclododecan-1-yl]propanoyl}amino)acetyl]-amino}methyl)-4,7,11,14-tetraazaheptadecan-2-yl}-1,4,7,10-tetraazacyclododecan-1-yl]acetate, with a molecular formula of C₈₁H₁₂₈Gd₄N₂₄O₃₂ and a molecular weight of 2,579.1 g/mol.

The structural formula of gadoquatrane is:

AMBELVIST is a sterile, clear, colorless to pale yellow solution. Each mL contains 257.9 mg (0.1 mmol) of gadoquatrane (containing 0.4 mmol of gadolinium) and the following inactive ingredients: 0.196 mg of calcobutrol, 3.14 mg of sodium chloride,1.21 mg of trometamol, hydrochloric acid (for pH adjustment), and water for injection.

The main physicochemical properties of AMBELVIST are listed in Table 2:

Table 2. Physicochemical Properties of AMBELVIST:

Parameter	Value
Osmolality at 37°C (mOsm/kg H₂O)	270 to 370
Viscosity at 20°C (mPa∙s)	2.55
Viscosity at 37°C (mPa∙s)	1.76
pH	6.9 to 7.9

Dosage Forms and Strengths

Injection: 0.1 mmol/mL of gadoquatrane as a clear and colorless to pale yellow solution available as:

Strength	Package Type
• 0.2 mmol/2 mL (0.1 mmol/mL) • 0.75 mmol/7.5 mL (0.1 mmol/mL) • 1 mmol/10 mL (0.1 mmol/mL) • 1.5 mmol/15 mL (0.1 mmol/mL)	Single-Dose Vials
• 0.75 mmol/7.5 mL (0.1 mmol/mL) • 1 mmol/10 mL (0.1 mmol/mL) • 1.5 mmol/15 mL (0.1 mmol/mL)	Single-Dose Pre-Filled Syringes
• 3 mmol/30 mL (0.1 mmol/mL) • 6.5 mmol/65 mL (0.1 mmol/mL)	Imaging Bulk Packages
• 3 mmol/30 mL (0.1 mmol/mL) • 6.5 mmol/65 mL (0.1 mmol/mL)	Pharmacy Bulk Packages

How Supplied

AMBELVIST (gadoquatrane) injection is a clear and colorless to pale yellow solution available in the following presentations:

Strength	Package Type	Sale Unit	NDC
0.2 mmol/2 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 3 vials	50419-321-11
0.75 mmol/7.5 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 10 vials	50419-322-11
1 mmol/10 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 10 vials	50419-323-11
1.5 mmol/15 mL (0.1 mmol/mL)	Single-Dose Vial	Cartons of 10 vials	50419-324-11
0.75 mmol/7.5 mL (0.1 mmol/mL)	Single-Dose Pre-Filled Syringe	Cartons of 5 syringes	50419-330-11
1 mmol/10 mL (0.1 mmol/mL)	Single-Dose Pre-Filled Syringe	Cartons of 5 syringes	50419-331-11
1.5 mmol/15 mL (0.1 mmol/mL)	Single-Dose Pre-Filled Syringe	Cartons of 5 syringes	50419-332-11
3 mmol/30 mL (0.1 mmol/mL)	Imaging Bulk Package	Cartons of 10 bottles	50419-326-11
6.5 mmol/65 mL (0.1 mmol/mL)	Imaging Bulk Package	Cartons of 10 bottles	50419-327-11
3 mmol/30 mL (0.1 mmol/mL)	Pharmacy Bulk Package	Cartons of 10 bottles	50419-328-11
6.5 mmol/65 mL (0.1 mmol/mL)	Pharmacy Bulk Package	Cartons of 10 bottles	50419-329-11

Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981

Drugs

Drug	Countries
AMBELVIST	United States

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