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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-205
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fish oil (UNII: XGF7L72M0F)
(Fish oil - UNII:XGF7L72M0F) 		Fish oil 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
.alpha.-tocopherol, dl-(UNII: 7QWA1RIO01)
egg phospholipids(UNII: 1Z74184RGV)
sodium oleate(UNII: 399SL044HN)
glycerin(UNII: PDC6A3C0OX)
sodium hydroxide(UNII: 55X04QC32I)
water(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-205-5010 in 1 CARTON 27/07/2018
1NDC:63323-205-2150 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:63323-205-0010 in 1 CARTON 27/07/2018
2NDC:63323-205-31100 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210589 07/27/2018

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

PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Label

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

PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 50 mL Vial Carton Label

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

PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Label

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

PACKAGE LABEL- PRINCIPAL DISPLAY – Omegaven 100 mL Vial Carton Label