Figure 1 (Pombiliti 01)
Pombiliti Injection, Powder, Lyophilized, For Solution
Product Images NDC 71904-200
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Pombiliti (NDC 71904-200). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Amicus Therapeutics Us, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Figure 2 (Pombiliti 02)
Figure 3 (Pombiliti 03)
1 Count Carton Label (Pombiliti 04)
Dosage: See Prescribing Information. After reconstitution, the medication needs to be further diluted. POMBILITI should be used in combination with OPFOLDA™. The medication does not contain preservatives and comes in single-dose vials. Any unused portion should be discarded. It should be stored refrigerated at a temperature of 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light. It should not be frozen. POMBILITI is manufactured by Amicus Therapeutics US, LLC in Philadelphia, PA. The medication is for intravenous infusion after reconstitution and dilution. It contains 105 mg per vial. This medication requires a prescription.*
1 Count Vial Label (Pombiliti 05)
This text appears to be a description of a medication called "Pombiliti". It is a drug that comes in single-dose vials and contains 105 mg of cg)aglucosidase alfa-atga, along with other inactive ingredients such as citric acid monohydrate, mannitol, polysorbate 80, and sodium citrate. The pH of the drug is between 5.7-6.3 and it does not contain any preservatives. The vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) and should not be frozen. After reconstitution with sterile water, the concentration of the drug is 105 mg/7 mL (15mg/mL) and it can be stored for up to 24 hours when refrigerated. The description also mentions a website where healthcare professionals can access preparation instructions and other helpful information, as well as a phone number for questions. The medication is used in conjunction with another drug called "Opfolda" and is manufactured by Amicus Therapeutics.*
10 Count Multipack Label (Pombiliti 06)
25 Count Multipack Label (Pombiliti 07)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
