Ambelvist Injection
Product Images NDC 50419-330

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Ambelvist (NDC 50419-330). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bayer Healthcare Pharmaceuticals Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Chemical Structure (Gadoquatrane 01)

FDA Label Image

Principal Display Panel (2 mL Vial Carton)

Principal Display Panel (2 mL Vial Carton)
This text appears to be an excerpt from a product description for "Ambelvist" (gadodiamide) injection in a 3x2mL dosage. The injection is a sterile solution containing 0.2 mmol/2 mL (0.1 mmol/mL) and is intended for intravenous administration. It is supplied in single-dose vials, and any unused portion should be discarded. Prescribing information instructs to dispense the enclosed Medication Guide to each patient. The product has an NDC code of 50419-321-11.*
FDA Label Image

Principal Display Panel (7.5 mL Vial Carton)

Principal Display Panel (7.5 mL Vial Carton)
This is a prescription medication with the NDC 50419-322-11 for Ambelvist injection. The medication contains gadoquatran and is available in a 10x7.5mL vial with a concentration of 0.75 mmol/7.5 mL (0.2 mmol/mL). It is a sterile solution for intravenous administration and is designated for single-dose use. Make sure to discard any unused portion and provide the enclosed Medication Guide to each patient.*
FDA Label Image

Principal Display Panel (10 mL Vial Carton)

Principal Display Panel (10 mL Vial Carton)
This text provides details about Ambelvist® (gadoquatrane) injection, which is offered in single-dose vials containing 10x10mL of a sterile solution. The solution has a concentration of 1mmol/10mL (0.1mmol/mL) and is for intravenous administration. It also mentions to discard any unused portion and dispense the enclosed Medication Guide to each patient. The National Drug Code (NDC) for this product is 50419-323-11.*
FDA Label Image

Principal Display Panel (15 mL Vial Carton)

Principal Display Panel (15 mL Vial Carton)
This is a description of Ambelvist, a medication in injection form containing gadoquatrane at a concentration of 1.5 mmol per 15 mL (0.1 mmol/mL). It is intended for intravenous administration and comes in single-dose vials of 10x15mL. The text also mentions the importance of discarding any unused portion and dispensing the enclosed Medication Guide to each patient.*
FDA Label Image

Principal Display Panel (30 mL Vial Carton)

Principal Display Panel (30 mL Vial Carton)
This is a prescription information for Ambelvist®, an injection containing gadoquatrane. It comes in a bulk pack of 10 vials, each containing 30 mL of a sterile solution with a concentration of 3 mmol/30 mL (0.1 mmol/mL). It is for use by prescription only and is not for direct infusion. The medication should be discarded 6 hours after initial puncture, and patients should be provided with a Medication Guide.*
FDA Label Image

Principal Display Panel (65 mL Bottle Label)

Principal Display Panel (65 mL Bottle Label)
This text contains information about Ambelvist, an injectable contrast agent used for imaging purposes. It provides details on dosage, storage instructions, and the manufacturer (Bayer HealthCare Pharmaceuticals Inc.). The product is for intravenous use only and should be discarded 6 hours after initial puncture. It should be used with approved contrast injection systems and comes in a 65 mL package. The composition includes gadoquatrane, calcobutrol, sodium chloride, trometamol, hydrochloric acid, and water for injection. Each mL contains 257.9 mg of gadoquatrane. The medication guide should be dispensed to each patient. It should be stored at 25°C with excursions permitted between 15-30°C. Additional details can be found in the prescribing information and on the drug and device labeling.*
FDA Label Image

Principal Display Panel (30 mL Bottle Carton)

Principal Display Panel (30 mL Bottle Carton)
Description: The product is Ambelvist®, which is a pharmacy bulk package injection containing Gadoquatrate. It comes in a pack of 10 vials, each containing 30mL of a sterile solution with a concentration of 3 mmol/30 mL (0.1 mmol/mL). This medication should not be directly infused and must be discarded 6 hours after initial puncture. A Medication Guide is included to be dispensed to each patient. The product's National Drug Code is 50419-328-11.*
FDA Label Image

Principal Display Panel (65 mL Bottle Label)

Principal Display Panel (65 mL Bottle Label)
This text is a detailed description of Ambelvist®, a gadolinium injection for intravenous use. It provides information on the dosage, components, storage instructions, and expiration details. The medication guide should be provided to each patient, and the product should be discarded 6 hours after initial puncture. The solution does not contain any antimicrobial preservatives and is intended for pharmacy bulk package use only. The manufacturer is Bayer HealthCare Pharmaceuticals Inc., located in Whippany, New Jersey, with the product manufactured in Germany.*
FDA Label Image

Principal Display Panel (7.5 mL Syringe Carton)

Principal Display Panel (7.5 mL Syringe Carton)
Description: This text provides details about Ambelvist®, a gadoquatrane injection available in pre-filled syringes with a concentration of 0.75 mmol/7.5 mL (0.1 mmol/mL). The medication is for intravenous administration and is a single-dose syringe. Instructions state to discard any unused portion and the syringe after use. It emphasizes that the medication and fluid pathway are sterile, but the outside of the syringe is not sterile. Each patient should be given a Medication Guide when dispensing the product in its 5x7.5mL pre-filled syringes.*
FDA Label Image

Principal Display Panel (10 mL Syringe Carton)

Principal Display Panel (10 mL Syringe Carton)
Description: This is information about Ambelvist® (gadoquatrane) injection prefilled syringes with a concentration of 1 mmol/10 mL (0.1 mmol/mL). The syringes are designed for single-dose use and for intravenous administration. This disposable 10 mL syringe should be discarded after use and the enclosed Medication Guide should be provided to each patient. The medication and fluid pathway are sterile, while the outside of the syringe is not sterile.*
FDA Label Image

Principal Display Panel (15 mL Syringe Carton)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.