omegaven

Generic: fish oil

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name omegaven
Generic Name fish oil
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients

fish oil .1 g/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-205
Product ID 63323-205_5cdc585d-835d-4092-850c-12adbcdef9b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210589
Listing Expiration 2026-12-31
Marketing Start 2018-07-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323205
Hyphenated Format 63323-205

Supplemental Identifiers

RxCUI
2053499 2053504 2053513 2053514
UNII
XGF7L72M0F

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omegaven (source: ndc)
Generic Name fish oil (source: ndc)
Application Number NDA210589 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .1 g/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31)
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21)
source: ndc

Packages (2)

63323-205-00 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31) 63323-205-50 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21)

Ingredients (1)

fish oil (.1 g/mL)

Linked Drug Pages (1)

Omegaven ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5cdc585d-835d-4092-850c-12adbcdef9b9", "openfda": {"unii": ["XGF7L72M0F"], "rxcui": ["2053499", "2053504", "2053513", "2053514"], "spl_set_id": ["5d9d0b24-e139-48bf-ab2d-536fb59cf8e0"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00)  / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31)", "package_ndc": "63323-205-00", "marketing_start_date": "20180727"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50)  / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21)", "package_ndc": "63323-205-50", "marketing_start_date": "20180727"}], "brand_name": "Omegaven", "product_id": "63323-205_5cdc585d-835d-4092-850c-12adbcdef9b9", "dosage_form": "INJECTION, EMULSION", "product_ndc": "63323-205", "generic_name": "Fish oil", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omegaven", "active_ingredients": [{"name": "FISH OIL", "strength": ".1 g/mL"}], "application_number": "NDA210589", "marketing_category": "NDA", "marketing_start_date": "20180727", "listing_expiration_date": "20261231"}