smoflipid

Generic: smoflipid

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

Drug Facts

Product Profile

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

fish oil 3 g/100mL, medium-chain triglycerides 6 g/100mL, olive oil 5 g/100mL, soybean oil 6 g/100mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-820
Product ID 63323-820_9fd35691-76ee-486c-bd65-b47d3df2fef4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207648
Listing Expiration 2026-12-31
Marketing Start 2016-07-13

Pharmacologic Class

Established (EPC)
lipid emulsion [epc]
Chemical Structure
lipids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323820
Hyphenated Format 63323-820

Supplemental Identifiers

UNII
XGF7L72M0F C9H2L21V7U 6UYK2W1W1E 241ATL177A
NUI
N0000191261 M0012553

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 smoflipid (source: ndc)
Generic Name smoflipid (source: ndc)
Application Number NDA207648 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 3 g/100mL
  • 6 g/100mL
  • 5 g/100mL
source: ndc
Packaging
  • 10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01)
  • 6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05)
  • 20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02)
  • 12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03)
  • 10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04)
source: ndc

Packages (5)

63323-820-00 10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01) 63323-820-10 6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) 63323-820-12 20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02) 63323-820-50 12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03) 63323-820-74 10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04)

Ingredients (4)

fish oil (3 g/100mL) medium-chain triglycerides (6 g/100mL) olive oil (5 g/100mL) soybean oil (6 g/100mL)

Linked Drug Pages (1)

Smoflipid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9fd35691-76ee-486c-bd65-b47d3df2fef4", "openfda": {"nui": ["N0000191261", "M0012553"], "unii": ["XGF7L72M0F", "C9H2L21V7U", "6UYK2W1W1E", "241ATL177A"], "spl_set_id": ["e0e9d917-ff6f-488e-a6a8-0ad59dd17d80"], "pharm_class_cs": ["Lipids [CS]"], "pharm_class_epc": ["Lipid Emulsion [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CASE (63323-820-00)  / 100 mL in 1 BAG (63323-820-01)", "package_ndc": "63323-820-00", "marketing_start_date": "20160713"}, {"sample": false, "description": "6 BAG in 1 CASE (63323-820-10)  / 1000 mL in 1 BAG (63323-820-05)", "package_ndc": "63323-820-10", "marketing_start_date": "20190527"}, {"sample": false, "description": "20 BAG in 1 CASE (63323-820-12)  / 100 mL in 1 BAG (63323-820-02)", "package_ndc": "63323-820-12", "marketing_start_date": "20160713"}, {"sample": false, "description": "12 BAG in 1 CASE (63323-820-50)  / 500 mL in 1 BAG (63323-820-03)", "package_ndc": "63323-820-50", "marketing_start_date": "20160713"}, {"sample": false, "description": "10 BAG in 1 CASE (63323-820-74)  / 250 mL in 1 BAG (63323-820-04)", "package_ndc": "63323-820-74", "marketing_start_date": "20160713"}], "brand_name": "Smoflipid", "product_id": "63323-820_9fd35691-76ee-486c-bd65-b47d3df2fef4", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["Lipid Emulsion [EPC]", "Lipid Emulsion [EPC]", "Lipids [CS]", "Lipids [CS]"], "product_ndc": "63323-820", "generic_name": "Smoflipid", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Smoflipid", "active_ingredients": [{"name": "FISH OIL", "strength": "3 g/100mL"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "strength": "6 g/100mL"}, {"name": "OLIVE OIL", "strength": "5 g/100mL"}, {"name": "SOYBEAN OIL", "strength": "6 g/100mL"}], "application_number": "NDA207648", "marketing_category": "NDA", "marketing_start_date": "20160713", "listing_expiration_date": "20261231"}