Omegaven Injection, Emulsion
Product Images NDC 63323-205

12 FDA label images from Fresenius Kabi Usa, Llc · 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 Omegaven (NDC 63323-205). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, 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.

FDA Label Image

Ome04 0003 01

Ome04 0003 01
Chemical structure of fish oil as shown in the diagram, depicting the molecular arrangement of triglycerides with three fatty acid chains attached to a glycerol backbone.*
FDA Label Image

Ome04 0003 02

Ome04 0003 02
Chemical structure of the active ingredient fish oil in Omegaven injection, emulsion. The image depicts a simplified molecular structure focusing on a specific moiety, highlighting carbonyl and hydroxyl functional groups.*
FDA Label Image

Ome04 0003 03

Ome04 0003 03
Chemical structure of the active ingredient fish oil in Omegaven 0.1 g/mL intravenous injection emulsion by Fresenius Kabi USA, LLC. The structure shows fatty acid chains typical of fish oil triglycerides.*
FDA Label Image

Ome04 0003 04

Ome04 0003 04
Chemical structure diagram of the active ingredient fish oil in Omegaven injection emulsion. The diagram shows a molecular structure with carbon, oxygen, and hydrogen atoms arranged in the characteristic pattern of a fatty acid molecule.*
FDA Label Image

Ome04 0003 05

Ome04 0003 05
Chemical structures of multiple fatty acids found in Fish oil, including EPA, DHA, Palmitic acid, Oleic acid, Palmitoleic acid, Linoleic acid, Myristic acid, Arachidonic acid, and Alpha-linolenic acid. Each structure shows the molecular formula and arrangement of carbon (C), hydrogen (H), and oxygen (O) atoms.*
FDA Label Image

Ome04 0003 06

Ome04 0003 06
A set of four line graphs showing mean concentrations with standard deviation for fatty acids over 11 weeks in patients receiving Omegaven fish oil injection emulsion. The top two graphs compare Docosahexaenoic acid and Eicosapentaenoic acid levels exclusively on Omegaven and concurrent with enteral nutrition. The bottom two graphs show Alpha-linolenic acid, Arachidonic acid, and Linoleic acid concentrations under the same conditions.*
FDA Label Image

Ome04 0003 07

Ome04 0003 07
A line graph comparing median body weight adjusted for age (Z-score) over time in weeks for two studies. The x-axis represents analysis visits in weeks from baseline (BL) to 132 weeks, while the y-axis shows median body weight Z-scores, ranging from -3.5 to 3.5. Two lines labeled Study 1 and Study 2 track changes with error bars indicating variability at each point.*
FDA Label Image

Ome04 0003 08

FDA Label Image

Ome04 0003 09

Ome04 0003 09
Omegaven injection, emulsion with fish oil triglycerides, 5 grams per 50 mL (0.1 grams per mL). The label states energy content of 56 kcal per 50 mL, intended for intravenous use only. This bottle is a 50 mL single-dose vial with instructions to discard unused portion. Labeler is Fresenius Kabi USA, LLC.*
FDA Label Image

Ome04 0003 10

Ome04 0003 10
Omegaven (fish oil triglycerides) injectable emulsion label showing a 5 grams per 50 mL (0.1 grams per mL) dosage. This single-dose bottle label is for intravenous use and contains 10 x 50 mL. Manufactured by Fresenius Kabi Austria GmbH, the label includes storage instructions and notes the product is sterile and latex-free.*
FDA Label Image

Ome04 0003 11

Ome04 0003 11
Omegaven (fish oil triglycerides) injectable emulsion label showing 10 grams per 100 mL (0.1 grams per mL) strength. The label states energy content of 112 kcal per 100 mL and specifies intravenous use only. The packaging is for a 100 mL single-dose bottle, with discard unused portion instructions. Labeler is Fresenius Kabi USA, LLC.*
FDA Label Image

Ome04 0003 12

Ome04 0003 12
Omegaven (fish oil triglycerides) injectable emulsion label for intravenous use. Strength is 10 grams per 100 mL (0.1 grams per mL) in a single-dose bottle. The label includes storage instructions, manufacturer Fresenius Kabi Austria GmbH, and barcode information. It specifies the product is sterile and latex-free.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.