NDC Code(s) : 63323-205-21, 63323-205-50, 63323-205-31, 63323-205-00
Packager : Fresenius Kabi USA, LLC
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
Omegaven Fish oil INJECTION, EMULSION | ||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
LABELER - Fresenius Kabi USA, LLC (608775388) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Fresenius Kabi Austria | 300206604 | ANALYSIS(63323-205), MANUFACTURE(63323-205), PACK(63323-205) |
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Label
NDC 63323-205-21 255050
Omegaven ®
(fish oil triglycerides) Injectable emulsion
5 grams per 50 mL
(0.1 grams per mL)
Energy: 56 kcal per 50 mL
For intravenous use only. Rx only
50 mL Single-Dose bottle - Discard Unused Portion
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Carton Label
NDC 63323-205-50 255050
Omegaven ®
(fish oil triglycerides) Injectable emulsion
5 grams per 50 mL
(0.1 grams per mL)
For intravenous use only. Rx only
Sterile.
Store below 25°C. (77°F). Do not freeze.
Use only if the emulsion is homogeneous.
See prescribing information.
Not made with natural rubber latex
10 x 50 mL
Single-Dose bottle-
Discard Unused Portion
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Label
NDC 63323-205-31 255100
Omegaven ®
(fish oil triglycerides) Injectable emulsion
10 grams per 100 mL
(0.1 grams per mL)
Energy: 112 kcal per 100 mL
For intravenous use only. Rx only
100 mL Single-Dose bottle - Discard Unused Portion
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Carton Label
NDC 63323-205-00 255100
Omegaven ®
(fish oil triglycerides) Injectable emulsion
10 grams per 100 mL
(0.1 grams per mL)
For intravenous use only. Rx only
Sterile.
Store below 25°C. (77°F). Do not freeze.
Use only if the emulsion is homogeneous.
See prescribing information.
Not made with natural rubber latex
10 x 100 mL Single-Dose bottle-
Discard Unused Portion