clinolipid

Generic: olive oil and soybean oil

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clinolipid
Generic Name olive oil and soybean oil
Labeler baxter healthcare corporation
Dosage Form INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients

olive oil 16 g/100mL, soybean oil 4 g/100mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-9540
Product ID 0338-9540_c5a33738-e548-42a3-9085-92b4af29d4f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204508
Listing Expiration 2026-12-31
Marketing Start 2016-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03389540
Hyphenated Format 0338-9540

Supplemental Identifiers

RxCUI
1986373 1986378 1986381 1986382 1986385 1986386 1986388 1986389
UNII
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 clinolipid (source: ndc)
Generic Name olive oil and soybean oil (source: ndc)
Application Number NDA204508 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 16 g/100mL
  • 4 g/100mL
source: ndc
Packaging
  • 15 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01)
  • 10 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02)
  • 12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03)
  • 6 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04)
source: ndc

Packages (4)

0338-9540-05 15 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01) 0338-9540-06 10 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02) 0338-9540-07 12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) 0338-9540-08 6 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04)

Ingredients (2)

olive oil (16 g/100mL) soybean oil (4 g/100mL)

Linked Drug Pages (1)

Clinolipid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c5a33738-e548-42a3-9085-92b4af29d4f2", "openfda": {"nui": ["N0000191261", "M0012553"], "unii": ["6UYK2W1W1E", "241ATL177A"], "rxcui": ["1986373", "1986378", "1986381", "1986382", "1986385", "1986386", "1986388", "1986389"], "spl_set_id": ["ae98eb03-c0e7-49d1-b024-77968e3d9d6e"], "pharm_class_cs": ["Lipids [CS]"], "pharm_class_epc": ["Lipid Emulsion [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 BAG in 1 CARTON (0338-9540-05)  / 100 mL in 1 BAG (0338-9540-01)", "package_ndc": "0338-9540-05", "marketing_start_date": "20160101"}, {"sample": false, "description": "10 BAG in 1 CARTON (0338-9540-06)  / 250 mL in 1 BAG (0338-9540-02)", "package_ndc": "0338-9540-06", "marketing_start_date": "20160101"}, {"sample": false, "description": "12 BAG in 1 CARTON (0338-9540-07)  / 500 mL in 1 BAG (0338-9540-03)", "package_ndc": "0338-9540-07", "marketing_start_date": "20160101"}, {"sample": false, "description": "6 BAG in 1 CARTON (0338-9540-08)  / 1000 mL in 1 BAG (0338-9540-04)", "package_ndc": "0338-9540-08", "marketing_start_date": "20160101"}], "brand_name": "Clinolipid", "product_id": "0338-9540_c5a33738-e548-42a3-9085-92b4af29d4f2", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["Lipid Emulsion [EPC]", "Lipid Emulsion [EPC]", "Lipids [CS]", "Lipids [CS]"], "product_ndc": "0338-9540", "generic_name": "Olive Oil and Soybean Oil", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clinolipid", "active_ingredients": [{"name": "OLIVE OIL", "strength": "16 g/100mL"}, {"name": "SOYBEAN OIL", "strength": "4 g/100mL"}], "application_number": "NDA204508", "marketing_category": "NDA", "marketing_start_date": "20160101", "listing_expiration_date": "20261231"}