Home › NDC Lookup › Ingredients › Olive Oil And Soybean Oil › 00338-9540-08
Clinolipid Olive Oil and Soybean 16 g/100mL; 4 g/100mL Injection, Emulsion — NDC 00338-9540-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clinolipid Olive Oil and Soybean 16 g/100mL; 4 g/100mL Injection, Emulsion — NDC 0338-9540-08 (Billing 00338-9540-08)

by Baxter Healthcare Corporation · 6 BAG in 1 CARTON / 1000 mL in 1 BAG

This is a package of Clinolipid Olive Oil and Soybean 16 g/100mL; 4 g/100mL Injection, Emulsion from Baxter Healthcare Corporation, marketed since Jan 2016 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 00338-9540-08
🏷️ FDA NDC (as labeled) 0338-9540-08 billing pads the labeler segment with a zero
This package
Contains1000 mL in 1 bag Medicaid pays$0.1764 / unit · 12 mo Per package$1,058.40 / 6000 ml · Medicaid Pack sizes4 compare ↓
Also priced by: Part D plans $0.0845/unit — full pricing hub ↓
Main listing for product 0338-9540 · Also comes in: 100 ml 0338-9540-05 250 ml 0338-9540-06 500 ml 0338-9540-07
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0338-9540-08 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 9540 product · 08 package
Package marketed since
Jan 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0338954008 3
Medicaid fills, this package
4,730 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-9540-08
Product NDC 0338-9540
11-digit billing NDC 00338954008
NCPDP billing unit ML — per mL (volume)
RxCUI 1986373, 1986378, 1986381, 1986382, 1986385, 1986386, 1986388, 1986389
UNII 6UYK2W1W1E, 241ATL177A
Application # NDA204508
SPL Set ID ae98eb03-c0e7-49d1-b024-77968e3d9d6e
Established class (EPC) Lipid Emulsion
Chemical class Lipids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-01-01
Route INTRAVENOUS
Dosage form INJECTION, EMULSION
Substance OLIVE OIL; SOYBEAN OIL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 80200010601620
GPI class Clinolipid
GCN Seq No 058056
GCN 23372
HICL code 037112
Ingredient (HICL) Fat Emulsion/Olive,Soybean Oil
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4B
Therapeutic class — specific (HIC3) Iv Fat Emulsions
AHFS code 40:20.00.00
AHFS class Caloric Agents
FDB label name CLINOLIPID 20% (200 GM/1000ML)
FDB brand name Clinolipid
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058056
  • GCN: 23372
  • GPI-14 (Medi-Span): 80200010601620
  • HICL (First Databank): 037112
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 1986373
Why two NDCs? The FDA registers this code as 0338-9540-08 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00338-9540-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Lipid Emulsion class.

Pharmacologic class Lipid Emulsion
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CLINOLIPID 20% (200 GM/1000ML) Ingredient Fat Emulsion/Olive,Soybean Oil

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.1764 $1,058.40 / 6000 ml
Medicare drug plans payPart D · Q2 2026 $0.0845 $507.00 / 6000 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00338-9540-05 0338-9540-05 15 BAG in 1 CARTON / 100 mL in 1 BAG 2016-01-01 — Active
00338-9540-06 0338-9540-06 10 BAG in 1 CARTON / 250 mL in 1 BAG 2016-01-01 — Active
00338-9540-07 0338-9540-07 12 BAG in 1 CARTON / 500 mL in 1 BAG 2016-01-01 — Active
00338-9540-08 You're viewing this Main listing 6 BAG in 1 CARTON / 1000 mL in 1 BAG 2016-01-01 — Active

In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 bag in 1 carton / 1000 ml in 1 bag.
What NDC number is used to bill for this package of Clinolipid Olive Oil and Soybean 16 g/100mL; 4 g/100mL Injection, Emulsion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clinolipid 16 g/100mL; 4 g/100mLthis 00338-9540-08 Baxter 1000 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
First FDA approval
Oct 2013
📍
2026
Currently FDA-listed
13 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 3, 2013 RLD RS ⏳ ~0.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity NPP
2013 2015 2017 2019 2021 2023 2025 2027
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationApr 24, 2027
Common questions
Is there a generic version of CLINOLIPID 20% (200 GM/1000ML)?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for CLINOLIPID 20% (200 GM/1000ML). Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2027 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 1.20 g / 100 mL UNII 1Z74184RGV
    Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
  • 2.25 g / 100 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 0.03 g / 100 mL UNII 399SL044HN
    Sodium oleate is a salt derived from oleic acid, a natural fatty acid. In medicines, it acts as an emulsifier and surfactant, helping mix oil and water ingredients together and improving how the drug dissolves and spreads in the body.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBaxter Healthcare Corporation
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA204508 (NDA)
Labeler code00338
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio283 products on file

More NDCs from Baxter Healthcare Corporation labeler code 00338

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 81 words ▾

1 INDICATIONS AND USAGE CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINOLIPID is indicated in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Use a 1.2 micron in-line filter when administering to a patient. ( 2.1 ) • For infusion into a central or peripheral vein. ( 2.2 ) • See full prescribing information for administration and admixing instructions.

( 2.2 , 2.3 ) • CLINOLIPID Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures. ( 2.2 ) • Protect the admixed parenteral solution from light. ( 2.3 ) • Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient.

( 2.4 ) • For information on the age-appropriate infusion rate, see the full prescribing information. ( 2.4 , 5.1 ) Age Initial Dose Maximum Dose Birth to 2 years of age (including preterm and term neonates) 0.5 to 1 g/kg/day 3 g/kg/day Pediatric patients 2 to less than 12 years of age 1 to 2 g/kg/day 3 g/kg/day Pediatric patients 12 to 17 years of age 1 g/kg/day 3 g/kg/day Adults 1 to 1.5 g/kg/day 2.5 g/kg/day

2.1Use of an Inline Filter When Administering CLINOLIPID to a Patient Fragments of the administration port membrane could be dislodged into the bag after spiking. Use a 1.2 micron in-line filter during administration of CLINOLIPID (alone or as part of an admixture) to remove particulate matter or micro-precipitate contamination during administration of a lipid injection (alone or as part of an admixture). Particulate matter greater than 5 microns has the capability of obstructing blood flow through capillaries, which could lead to embolism and vascular occlusion.

Do not use filters of less than 1.2 micron pore size with lipid emulsions.

2.2Important Administration Instructions Before opening the overwrap, check the color of the oxygen indicator. Compare the color of the indicator to the reference color printed next to the OK symbol depicted in the printed area of the indicator label. Do not use the product if the color of the oxygen absorber/indicator does not correspond to the reference color printed next to the OK symbol.

After opening the bag, use the contents immediately and discard unused portion. Visually inspect that the emulsion is a homogeneous liquid with a milky appearance. Inspect for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not exceed the recommended maximum infusion rate (0.75 mL/kg/hour for pediatric patients and 0.5 mL/kg/hour for adults) [see Dosage and Administration (2.4 ) and Warnings and Precautions (5.1) ] . When Administering CLINOLIPID to a Patient : Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates.

Do not use vented administration sets with the vent in the open position. This can result in air embolism. If CLINOLIPID is mixed with dextrose and/or amino acid solutions, check the compatibility before administration by inspecting the mixture closely for the presence of precipitates.

Formation of precipitates could result in vascular occlusion. CLINOLIPID can be administered via central or peripheral vein. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate.

Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Use only a 1.2 micron pore size in-line filter to administer CLINOLIPID. DO NOT use any size less than 1.2 micron pore size in-line filter [see Dosage and Administration (2.1) ] .

CLINOLIPID 100 mL, 250 mL and 500 mL single-dose Flexible Containers: • After removing the overpouch, infuse immediately. If not used immediately, the product should be stored for no longer than 24 hours at no more than… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 143 words ▾

3 DOSAGE FORMS AND STRENGTHS CLINOLIPID is a sterile, homogenous, white, milky, lipid injectable emulsion supplied as: • 20% (20 g/100 mL)(0.2g/mL) of lipid in 100 mL single-dose Flexible Container • 20% (50 g/250 mL)(0.2g/mL) of lipid in 250 mL single-dose Flexible Container • 20% (100 g/500 mL)(0.2g/mL) of lipid in 500 mL single-dose Flexible Container • 20% (200 g/1,000 mL)(0.2g/mL) of lipid in 1,000 mL Pharmacy Bulk Package Injectable emulsion: • 20% (20 g/100 mL) (0.2 g/mL) of lipid in 100 mL single-dose flexible container ( 3 ) • 20% (50 g/250 mL) (0.2 g/mL) of lipid in 250 mL single-dose flexible container ( 3 ) • 20% (100 g/500 mL) (0.2 g/mL) of lipid in 500 mL single-dose flexible container ( 3 ) • 20% (200 g/1,000 mL) (0.2 g/mL) of lipid in 1,000 mL Pharmacy Bulk Package ( 3 )

⛔ Contraindications 94 words ▾

4 CONTRAINDICATIONS The use of CLINOLIPID is contraindicated in patients with the following: • Known hypersensitivity to egg, soybean, peanut or to any of the active or inactive ingredients in CLINOLIPID [see Warnings and Precautions (5.3) ] . • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions (5.7) ] . • Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients. ( 4 ) • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).

( 4 , 5.7 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. ( 5.1 , 8.4 ) • Parenteral Nutrition-Associated Liver Disease : Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests: if abnormalities occur, consider discontinuation or dosage reduction.

( 5.2 , 8.4 ) • Hypersensitivity Reactions : Monitor for signs or symptoms. Discontinue infusion if reactions occur. ( 5.3 ) • Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency : Monitor for signs and symptoms; monitor laboratory parameters.

( 5.4 , 5.5 , 5.6 , 5.7 , 5.9 ) • Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm neonates. ( 5.8 , 8.4 )

5.1Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.75 mL/kg/hour [see Dosage and Administration (2.4) ] .

Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. The risk due to poor lipid clearance should be considered when administering intravenous lipid emulsions. Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels).

If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation [see Warnings and Precautions (5.5 , 5.7 ) and Overdosage (10) ] .

5.2Parenteral Nutrition Associated Liver Disease and Other Hepatobiliary Disorders Risk of Parenteral Nutrition-Associated Liver Disease Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure-associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid emulsions, including CLINOLIPID, have been associated with development of PNALD.

Monitor liver tests in patients treated with CLINOLIPID and consider discontinuation or dosage reduction if abnormalities occur. Other Hepatobiliary Disorders Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some PN-treated patients without preexisting liver disease. Monitor liver tests when administering CLINOLIPID.

Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to CLINOLIPID use.

5.3Hypersensitivity Reactions CLINOLIPID contains soybean oil and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. In postmarketing experience, anaphylaxis has been reported following CLINOLIPID administration [see Adverse Reactions (6.2 )] .

CLINOLIPID is contraindicated in patients with known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in CLINOLIPID [see Contraindications (4)]. If a hypersensitivity reaction occurs, stop infusion of CLINOLIPID immediately and initiate appropriate treatment and supportive measures.

5.4Infections Lipid emulsions, such as CLINOLIPID, can support microb… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions (5.1) ] • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions (5.2)] • Hypersensitivity reactions [see Warnings and Precautions (5.3) ] • Infections [see Warnings and Precautions (5.4) ] • Fat overload syndrome [see Warnings and Precautions (5.5) ] • Refeeding syndrome [see Warnings and Precautions (5.6) ] • Hypertriglyceridemia [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.8) ] • Essential Fatty Acid Deficiency [see Warnings and Precautions (5.9) ] Most common (≥5%) adverse drug reactions from clinical trials in adults were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia, and abnormal liver function tests.

Most common (≥5%) adverse reactions from clinical trials in pediatric patients were hyperbilirubinemia, patent ductus arteriosus, anemia, gastroesophageal reflux disease, bradycardia, feeding intolerance, neonatal intraventricular hemorrhage, increased alkaline phosphatase, atrial septal defect, hyponatremia, sepsis, and infantile apnea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The CLINOLIPID trials had small sample sizes and patients had a variety of underlying medical conditions both between different trials and within the individual trials. Patients had gastrointestinal diseases/dysfunction or were recovering from gastrointestinal or other surgeries, trauma, burns, or were afflicted by other chronic illness.

Adult Trials Commonly observed adverse reactions in 261 adult patients who received CLINOLIPID were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia, and abnormal liver function tests and occurred in 2 to 10 % of patients. The largest clinical trial in adult patients (Study 1) enrolled 48 subjects with different underlying diagnoses. Study 2 was a randomized, open label multicenter study that enrolled 22 subjects, aged 32-81 years, who required long-term parenteral nutrition.

The most common adverse reactions in Study 1 and Study 2 were infectious complications (urinary tract infection, septicemia, and fever of unknown origin), treatment emergent abnormalities on liver/gallbladder ultrasound and abnormalities of serum chemistries, principally, hepatic function tests. Adverse reactions reported with other intravenous lipid emulsions include hyperlipidemia, hypercoagulability, thrombophlebitis, and thrombocytopenia. Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly, and shock).

Pediatric Trials The safety of CLINOLIPID in pediatric patients was evaluated in Studies 3, 4, 5, and 6 [see Clinical Studies (14.2) ] . In Study 3, EFAD was defined by calculating the Holman index (the triene [Mead acid] to tetraene [arachidonic acid] ratio; T:T ratio > 0.4). Although no patient developed EFAD, one CLINOLIPID-treated patient who had a T:T ratio that increased from < 0.2 at baseline to > 0.2 at end of study treatment was considered at risk for EFAD.

This patient’s arachidonic and linoleic acid levels remained within the normal range. No soybean oil lipid emulsio… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 49 words ▾

7 DRUG INTERACTIONS No drug interaction studies have been performed with CLINOLIPID. Olive and soybean oils have a natural content of Vitamin K 1 that may counteract the anticoagulant activity of coumadin derivatives, including warfarin. The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Administration of the recommended dose of CLINOLIPID is not expected to cause major defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with lipid injectable emulsion. There are clinical considerations if CLINOLIPID is used in pregnant women [see Clinical Considerations ] .

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk: Severe malnutrition in a pregnant woman is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. It is not known whether the administration of CLINOLIPID to pregnant women provides adequate essential fatty acids to the developing fetus.

8.2Lactation Risk Summary There are no data available to assess the presence of CLINOLIPID and/or its active metabolite(s) in human milk, the effects on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLINOLIPID and any potential adverse effects on the breastfed child from CLINOLIPID or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of CLINOLIPID have been established as a source of calories and essential fatty acids for PN in pediatric patients, including term and preterm neonates, when oral or enteral nutrition is not possible, insufficient, or contraindicated. Use of CLINOLIPID in pediatric patients is supported by evidence from four studies that enrolled pediatric patients, including preterm and term neonates, and additional evidence from clinical studies in adults. Use of CLINOLIPID in older pediatric patients is supported by evidence from two studies in pediatric patients up to 9 years of age treated for a median of 15 and 56 days, respectively, with additional evidence from clinical studies in adults [see Clinical Studies (14.2) ] .

No clinically significant cases of EFAD were observed in short term pediatric clinical studies. However, one premature neonate in study 3 became at risk for EFAD after 14 days of treatment based on a Holman Index increase above 0.2. This patient’s arachidonic and linoleic acid levels remained within the normal range [see Adverse Reactions (6.1) ] .

Monitor pediatric patients for laboratory evidence of EFAD, including fatty acid profile (i.e., arachidonic acid) because they may be particularly vulnerable to neurologic complications if adequate amounts of essential fatty acids are not provided [see Warnings and Precautions (5.9) ] . In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal, has been reported [see Warnings and Precautions (5.1) ] . Because of immature renal function, preterm infants receiving prolonged treatment with CLINOLIPID may be at risk for aluminum toxicity [see Warnings and Precautions (5.8) ] .

8.5Geriatric Use Of the total number of subjects in clinical studies of CLINOLIPID, 21% were 65 and over, while 10% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 180 words ▾

8.1Pregnancy Risk Summary Administration of the recommended dose of CLINOLIPID is not expected to cause major defects, miscarriage, or other adverse maternal or fetal outcomes. No animal reproduction studies have been conducted with lipid injectable emulsion. There are clinical considerations if CLINOLIPID is used in pregnant women [see Clinical Considerations ] .

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk: Severe malnutrition in a pregnant woman is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. It is not known whether the administration of CLINOLIPID to pregnant women provides adequate essential fatty acids to the developing fetus.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of CLINOLIPID have been established as a source of calories and essential fatty acids for PN in pediatric patients, including term and preterm neonates, when oral or enteral nutrition is not possible, insufficient, or contraindicated. Use of CLINOLIPID in pediatric patients is supported by evidence from four studies that enrolled pediatric patients, including preterm and term neonates, and additional evidence from clinical studies in adults. Use of CLINOLIPID in older pediatric patients is supported by evidence from two studies in pediatric patients up to 9 years of age treated for a median of 15 and 56 days, respectively, with additional evidence from clinical studies in adults [see Clinical Studies (14.2) ] .

No clinically significant cases of EFAD were observed in short term pediatric clinical studies. However, one premature neonate in study 3 became at risk for EFAD after 14 days of treatment based on a Holman Index increase above 0.2. This patient’s arachidonic and linoleic acid levels remained within the normal range [see Adverse Reactions (6.1) ] .

Monitor pediatric patients for laboratory evidence of EFAD, including fatty acid profile (i.e., arachidonic acid) because they may be particularly vulnerable to neurologic complications if adequate amounts of essential fatty acids are not provided [see Warnings and Precautions (5.9) ] . In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal, has been reported [see Warnings and Precautions (5.1) ] . Because of immature renal function, preterm infants receiving prolonged treatment with CLINOLIPID may be at risk for aluminum toxicity [see Warnings and Precautions (5.8) ] .

🧓 Geriatric Use 68 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of CLINOLIPID, 21% were 65 and over, while 10% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 60 words ▾

10 OVERDOSAGE In the event of overdose, serious adverse reactions may result [see Warnings and Precautions (5.1 , 5.5 )] . Stop the infusion to allow lipids to clear from serum. The effects are usually reversible after the lipid infusion is stopped. If medically appropriate, further intervention may be indicated. The lipid administered and fatty acids produced are not dialyzable.

🧬 Clinical Pharmacology 215 words ▾

12 CLINICAL PHARMACOLOGY CLINOLIPID administered intravenously provides biologically utilizable source of calories and essential fatty acids.

12.1Mechanism of Action Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

12.2Pharmacodynamics Infused essential fatty acids are synthesized into higher derivative fatty acids. Olive oil contains significant amounts of alpha-tocopherol that contributes to Vitamin E status.

12.3Pharmacokinetics Metabolism and Excretion The fatty acids, phospholipids, and glycerol found in lipid emulsions are metabolized by cells to carbon dioxide and water. The metabolism of these substances results in the generation of energy in the form of adenosine triphosphate (ATP). Some fatty acids are stored in the body in fat tissue, cell membranes, or as intracellular triglycerides.

There is constant turn-over of these tissues, with the result that the lipid components are eventually metabolized to carbon dioxide and water. Carbon dioxide is expired through the lungs. Water is excreted through the kidneys or lost through evaporation/expiration through the skin, lungs, and other tissue surfaces.

Some lipids (i.e., phospholipids, cholesterol, and bile acids) are excreted through the biliary system.

🧬 Mechanism of Action 53 words ▾

12.1Mechanism of Action Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING CLINOLIPID is a sterile, white, milky homogenous lipid injectable emulsion supplied in CLARITY polyolefin Flexible Containers as follows: Strengths Container Size Product Code NDC Number (1 Bag) NDC Number (Shelf Pack) 20% (20 g/100 mL) (0.2 g/mL) 100 mL EADB9520 0338-9540-01 (single-dose Flexible Container) 0338-9540-05 (15 pack) 20% (50 g/250 mL) (0.2 g/mL) 250 mL EADB9521 0338-9540-02 (single-dose Flexible Container) 0338-9540-06 (10 pack) 20% (100 g/500 mL) (0.2 g/mL) 500 mL EADB9523 0338-9540-03 (single-dose Flexible Container) 0338-9540-07 (12 pack) 20% (200 g/1,000 mL) (0.2 g/mL) 1,000 mL EADB9524 0338-9540-04 (Pharmacy Bulk Package bag) 0338-9540-08 (6 pack) The CLARITY Container is a lipid-compatible plastic container (PL 2401-1).

The bag is packaged in an oxygen barrier overpouch, which contains an oxygen absorber / oxygen indicator sachet. CLINOLIPID should be stored at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30 °C (59°F to 86°F).

See USP Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Store in overpouch until ready to use. CLINOLIPID 100 mL, 250 mL and 500 mL single-dose Flexible Containers : After removing the overpouch, infuse immediately. If not used immediately, the product should be stored for no longer than 24 hours at not more than 25°C (77°F) [ See Dosage and Administration (2.2) ].

CLINOLIPID 1,000 mL Pharmacy Bulk Package : Use the pharmacy bulk package immediately for admixing after removal from overpouch. If not used immediately, the product should be stored for no longer than 24 hours at not more than 25°C (77°F) [ see Dosage and Administration (2.2) ].

📋 Description ~1 min read ▾

11 DESCRIPTION CLINOLIPID lipid injectable emulsion, USP is a sterile, non-pyrogenic, homogenous, white, milky lipid emulsion for intravenous infusion. The lipid content of CLINOLIPID is 0.2 g/mL and comprises a mixture of refined olive oil and refined soybean oil in an approximate ratio of 4:1 (olive:soy). The mean concentration of linoleic acid (an omega-6 essential fatty acid) is 35.8 mg/mL (range 27.6 to 44.0 mg/mL) and α-linolenic acid (an omega-3 essential fatty acid) is 4.7 mg/mL (range 1.0 to 8.4 mg/mL).

The phospholipids provide 470 milligrams or 15 mmol of phosphorus per liter. The total energy content, including fat, phospholipids and glycerin is 2000 kcal/L. Each 100 mL of CLINOLIPID 20% contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, and Water for Injection USP.

Sodium Hydroxide NF for pH adjustment, pH: 6.0 to 9.0. The olive and soybean oils are refined natural products consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: The major component fatty acids are linoleic (13.8 to 22.0%), oleic (44.3 to 79.5%), palmitic (7.6 to 19.3%), linolenic (0.5 to 4.2%), palmitoleic (0.0 to 3.2%) and stearic (0.7 to 5.0%). These fatty acids have the following chemical and structural formulas: CLINOLIPID has an osmolality of approximately 340 mOsmol/kg water (which represents an osmolarity of 260 mOsmol/liter of emulsion).

CLINOLIPID contains no more than 25 mcg/L of aluminum. Structural Formula 1 Structural Formula 2

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION When initiating CLINOLIPID administration, discuss the following information with the patient or caregiver: Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders Inform patients and caregivers that use of parenteral nutrition may result in parenteral nutrition-associated liver disease and/or other hepatobiliary disorders [see Warnings and Precautions (5.2) ]. Hypersensitivity Reactions Inform patients and caregivers that CLINOLIPID may cause hypersensitivity reactions, including anaphylaxis.

If CLINOLIPID is infused at home, instruct patients or caregivers to stop the infusion of CLINOLIPID immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing dizziness, fever, or chills [see Warnings and Precautions (5.3) ]. Infections Inform patients and caregivers that patients who receive CLINOLIPID are at risk of infection.

If CLINOLIPID is infused at home, instruct patients or caregivers to ensure aseptic techniques are used for the preparation and administration of CLINOLIPID and to monitor for signs and symptoms of infection [see Warnings and Precautions (5.4) ]. Fat Overload Syndrome Inform patients and caregivers that fat overload syndrome has been reported with the use of intravenous lipid emulsions. If CLINOLIPID is infused at home, instruct patients or caregivers to stop CLINOLIPID if signs or symptoms of fat overload syndrome occur [see Warnings and Precautions (5.5) ].

Refeeding Syndrome If the patient is severely malnourished, inform patients and caregivers that administering parenteral nutrition including CLINOLIPID may result in refeeding syndrome [see Warnings and Precautions (5.6) ]. Hypertriglyceridemia Inform patients and caregivers about the risks of hypertriglyceridemia with CLINOLIPID use [see Warnings and Precautions (5.7) ] . Aluminum Toxicity Inform patients and caregivers that prolonged PN administration in patients with renal impairment, including preterm neonates, may result in aluminum reaching toxic levels associated with central nervous system and bone toxicity [see Warnings and Precautions (5.8) ].

Preparation and Administration Instructions If it is acceptable for a patient or caregiver to administer CLINOLIPID at home, then provide recommendations on how to prepare, add compatible additives (when appropriate), administer, and store CLINOLIPID [see Dosage and Administration (2.1 , 2.2 )].

🧬 Pharmacokinetics 120 words ▾

12.3Pharmacokinetics Metabolism and Excretion The fatty acids, phospholipids, and glycerol found in lipid emulsions are metabolized by cells to carbon dioxide and water. The metabolism of these substances results in the generation of energy in the form of adenosine triphosphate (ATP). Some fatty acids are stored in the body in fat tissue, cell membranes, or as intracellular triglycerides.

There is constant turn-over of these tissues, with the result that the lipid components are eventually metabolized to carbon dioxide and water. Carbon dioxide is expired through the lungs. Water is excreted through the kidneys or lost through evaporation/expiration through the skin, lungs, and other tissue surfaces.

Some lipids (i.e., phospholipids, cholesterol, and bile acids) are excreted through the biliary system.

🧬 Pharmacodynamics 26 words ▾

12.2Pharmacodynamics Infused essential fatty acids are synthesized into higher derivative fatty acids. Olive oil contains significant amounts of alpha-tocopherol that contributes to Vitamin E status.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adult Clinical Studies Two clinical trials (Study 1 and Study 2) in adults compared CLINOLIPID to soybean oil-based intravenous lipid emulsion. Although Study 1 and Study 2 were not adequately designed to demonstrate noninferiority of CLINOLIPID to the soybean oil comparator, they support CLINOLIPID as a source of calories and essential fatty acids in adults. The lipid dosage was variable in Studies 1 and 2 and adjusted to the patient’s nutritional requirements.

Study 1 was a randomized, open-label, multicenter study. Forty-eight patients, aged 17 to 75 years, requiring total parenteral nutrition (TPN) for ≥15 days (mean 22 days) were enrolled and randomized to either CLINOLIPID or a soybean oil-based intravenous lipid emulsion. Nutritional efficacy was assessed by anthropometric indices (body weight, arm circumference, skin-fold thickness), biomarkers of protein metabolism (total protein, albumin) and lipid metabolism.

Anthropometric criteria (body weight, arm circumference, and skin fold thickness) were comparable for both groups. Mean total serum protein and albumin increased similarly in both groups. Study 2 was a randomized, open label multicenter study that enrolled 22 patients aged 32-81 years who required long-term parenteral nutrition.

Twelve patients received CLINOLIPID for a mean of 202 days (range 24 to 408 days) and 10 patients received the comparator lipid for a mean of 145 days (range 29-394 days). The two groups had similar outcomes for weight, weight loss, mid-arm circumference and triceps skinfold thickness.

14.2Pediatric Clinical Studies The efficacy of CLINOLIPID compared to a soybean oil-based lipid emulsions was evaluated in 179 pediatric patients in four randomized, active-controlled, parallel-group clinical studies. Three studies (161 patients) were double-blinded. Although the four pediatric clinical studies were not adequately designed to demonstrate the noninferiority of CLINOLIPID to the soybean oil comparator, they support CLINOLIPID as a source of calories and essential fatty acids in pediatric patients, including term and preterm neonates.

The 179 pediatric patients (89 treated with CLINOLIPID; 90 with comparator) consisted of 140 patients who were less than 1 month of age, 23 patients one month to less than two years old, and 16 patients two to less than 18 years old. Nutritional efficacy in pediatric patients, including preterm infants, was assessed by evaluating growth parameters, protein biomarkers, changes in triglyceride and cholesterol concentrations, and fatty acid parameters. Study 3 (NCT 04555044) randomized 102 patients (101 analyzed) to receive either CLINOLIPID (n = 50) or a soybean oil-based lipid emulsion (n = 51) as part of PN in the hospital setting.

Baseline characteristics and outcomes during the study were similar in the two groups. The majority of study patients (n=94, 93%) were preterm neonates born at less than 37 weeks of gestation. The median age at enrollment in this study was day one of life and the median gestational age of neonates was 29 weeks.

Eighty-five patients (84%) were very low birth weight, including 53 patients (52%) with a birth weight of 1000-1499 grams and 32 patients (32%) with a birthweight of less than 1000 g. Forty-one patients (41%) were Black, 42 (42%) were White, and 8 (8%) were Hispanic or Latino. In both study groups, the mean daily dose administered was approximately 2.3 g/kg/day (SD 0.8 g/kg/day), and the median duration of treatment was 8 days (range: 3 – 60 days; interquartile range [IQR]: 8 – 10 days).

The primary endpoint was at risk of developing EFAD, defined as triene:tetraene (T:T) ratio >0.4, which did not occur during the study in either treatment group. Secondary endpoints included incidence of parenteral nutrition-associated cholestasis (PNAC) defined as direct bilirubin ≥2 mg/dL with no other etiology identified. One patient in the CLINOLIPID group (2%) and two patients in the comparator group (3.9%) devel… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with CLINOLIPID have not been performed to evaluate the carcinogenic potential, mutagenic potential, or effects on fertility.

13.2Animal Toxicology and/or Pharmacology CLINOLIPID was evaluated in toxicity studies conducted in rats and dogs for up to 3 months. The principal signs of toxicity noted in the 3-month studies were: • Slight hemolytic anemia at 12 g/kg/day in rats and at 6 g/kg/day in dogs. These doses in rats and dogs are 4 and 2 times higher, respectively, than the maximum recommended pediatric dose (3 g/kg/day) of CLINOLIPID. • Dose-dependent decrease in urea levels in rats at 6 and 12 g/kg/day dose levels and in dogs at 3, 4.5 and 6 g/kg/day dose levels associated with decreased feed consumption. • Hypercholesterolemia in dogs at 3, 4.5 and 6 g/kg/day dose levels. • Hepatic pathology of lipid and pigmentary overload in male and female rats at 3, 6 and 12 g/kg/day dose levels and brownish-yellow pigmentation in vacuolated Kupffer cells in male and female dogs at 3, 4.5 and 6 g/kg/day dose levels with hepatocyte vacuolation in male dogs at 6 g/kg/day and female dogs at 4.5 and 6 g/kg/day dose levels. • Splenic pigmentation and vacuolization in rats at 3, 6 and 12 g/kg/day dose levels, and dogs in 4.5 and 6 g/kg/day dose levels.

At doses of 3 g/kg/day, slight lipid and pigmentary overload of the liver and vacuolization of Kupffer cells were observed in rats and dogs. At a dose of 12 g/kg/day in rats, hepatocellular vacuolation, granulomatous inflammation of the liver, hepatocellular necrosis and hemosiderosis of the liver and lipid deposits and splenic hemosiderosis, were observed. In dogs, at a dose of 6 g/kg/day, brownish-yellow pigmentation in the Kupffer cells of liver and spleen, hyperplasia of vacuolated Kupffer cells, hepatocyte vacuolization, a slight increase in the number of lipid storage cells (Ito cells) in the liver and macrophage vacuolization of the spleen were observed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 24 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with CLINOLIPID have not been performed to evaluate the carcinogenic potential, mutagenic potential, or effects on fertility.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.3 ) 7/2025

📄 Package Label / Principal Display Panel 191 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label 1000 mL EADB9524 NDC 0338-9540-04 Baxter Logo Clinolipid (Lipid Injectable Emulsion, USP) 20% 200 g/1000 mL (0.2 g/mL) Pharmacy Bulk Package Not For Direct Infusion Intravenous use only 1000 mL Energy Content 2000 kcal/L Each 100 mL contains approximately 16 g of Olive Oil NF and 4 g of Soybean Oil USP, 1.2 g Egg Phospholipids NF, 2.25 g Glycerin USP, 0.03 g Sodium Oleate, Water for Injection USP and Sodium Hydroxide NF for pH adjustment pH 6.0–9.0 Osmolarity 260 mOsmol/L (calc) Cautions Use only if the color of the oxygen indicator is within allowable range Do not use unless emulsion has homogeneous milky appearance Once container closure has been penetrated withdrawal of contents should be completed without delay.

Dispense contents within 4 hours after initial entry. See prescribing information for proper use of Pharmacy Bulk Package. Store at 20 to 25 °C (68 to 77 °F) See USP Controlled Room Temperature Protect from freezing Rx Only Bar code appears here, and is printed on line during production.

Baxter Healthcare Corporation BE-35-04-865 EXP YYY-MM LOT 1000 750 500 250 100 Clinolipid Representative Container Label 0338-9540-04.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.7K
Units reimbursed last 4 qtrs
5.8M
Gross reimbursed last 4 qtrs
$1.02M
Avg / prescription
$215.01
Avg / unit
$0.1764
Latest quarter Q1 2026
1KRx
Fee-for-service vs managed care ⓘ
57% FFS 43% MCO
Fee-for-service · 2,701 Rx Managed care · 2,029 Rx
State Medicaid map
Alaska: 7,488 units · 1,022 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: 96,600 units · 4,919 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 34,234 units · 809 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 559,036 units · 4,455 per 100k residents IL Indiana: no data reported IN Ohio: 312,510 units · 2,652 per 100k residents OH Pennsylvania: 203,600 units · 1,571 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,330,434 units · 3,414 per 100k residents CA Utah: no data reported UT Colorado: 193,154 units · 3,286 per 100k residents CO Nebraska: no data reported NE Missouri: 35,000 units · 565 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 48,100 units · 552 per 100k residents VA Maryland: no data reported MD Connecticut: 47,980 units · 1,327 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,797,390 units · 37,645 per 100k residents AZ New Mexico: 74 units · 3.5 per 100k residents NM Kansas: 413 units · 14.0 per 100k residents KS Arkansas: no data reported AR Tennessee: 80,290 units · 1,127 per 100k residents TN North Carolina: 17,700 units · 163 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.537,645
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Arizona 37,645 /100k
2 Idaho 4,919 /100k
3 Illinois 4,455 /100k
4 California 3,414 /100k
5 Colorado 3,286 /100k
6 Ohio 2,652 /100k
7 Pennsylvania 1,571 /100k
8 Connecticut 1,327 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 ml this page00338-9540-08 4,730 Rx · $1,017,007
100 ml00338-9540-05 720 Rx · $56,721
250 ml00338-9540-06 230 Rx · $106,773
500 ml00338-9540-07 134 Rx · $54,868
Drug total (last 4 qtrs): 5,814 Rx · 6,302,844 units · $1,235,369 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clinolipid — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clinolipid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.45M
Claims incl. refills
4.9K
Beneficiaries
517
Spend / beneficiary
$2,797.77
Spend / claim
$293.70
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Baxter Healthcare Corporation. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 100 ml (00338-9540-05), 250 ml (00338-9540-06), 500 ml (00338-9540-07). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Baxter Healthcare Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00338-9159-30 · Baxter 00338-9541-24 · Baxter →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.