NDC 63323-205

Omegaven

Fish Oil

Omegaven is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Fish Oil.

• Product ID: 63323-205_9f02ef06-30e8-463c-8826-f453736f3457
• NDC: 63323-205
• Product Type: Human Prescription Drug
• Proprietary Name: Omegaven
• Generic Name: Fish Oil
• Dosage Form: Injection, Emulsion
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-07-27
• Marketing Category: NDA / NDA
• Application Number: NDA210589
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: FISH OIL
• Active Ingredient Strength: 0 g/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63323-205-00

10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) > 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31)

• Marketing Start Date: 2018-07-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-205-21 [63323020521]

Omegaven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA210589
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-27

NDC 63323-205-31 [63323020531]

Omegaven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA210589
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-27

NDC 63323-205-50 [63323020550]

Omegaven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA210589
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-27

NDC 63323-205-00 [63323020500]

Omegaven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA210589
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-27

Drug Details