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United States · US · US:63323-205_5cdc585d-835d-4092-850c-12adbcdef9b9
Omegaven
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633232050010 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31)
- ndc11633232055010 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21)
Annotations
UNII (FDA Substance ID)
XGF7L72M0F
FISH OIL
RxCUI 4419
Orange Book
N210589
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XGF7L72M0F",
"rxcui": "4419",
"inchikey": null,
"display_name": "FISH OIL",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5d9d0b24-e139-48bf-ab2d-536fb59cf8e0": {
"match": "brand_token",
"title": "OMEGAVEN (FISH OIL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC]",
"spl_version": "6",
"published_date": "2025-09-29"
}
},
"productid": "63323-205_5cdc585d-835d-4092-850c-12adbcdef9b9",
"productndc": "63323-205",
"dosage_form": "INJECTION, EMULSION",
"orange_book": {
"appl_no": "210589",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5GM/50ML (0.1GM/ML)",
"product_no": "001",
"approval_date": "Jul 27, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10GM/100ML (0.1GM/ML)",
"product_no": "002",
"approval_date": "Jul 27, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FISH OIL",
"proprietary_name": "Omegaven",
"active_ingred_unit": "g/mL",
"application_number": "NDA210589",
"marketing_category": "NDA",
"nonproprietary_name": "Fish oil",
"start_marketing_date": "20180727",
"active_numerator_strength": ".1"
}Access this data programmatically
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