Home › NDC Lookup › 00338-0519-13
Intralipid I.V. Fat Emulsion 20 g/100mL Emulsion, 500 mL — NDC 00338-0519-13 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Intralipid I.V. Fat Emulsion 20 g/100mL Emulsion, 500 mL — NDC 0338-0519-13 (Billing 00338-0519-13)

by Baxter Healthcare Corporation · 500 mL in 1 BAG

This is a package of 500 mL of Intralipid I.V. Fat Emulsion 20 g/100mL Emulsion from Baxter Healthcare Corporation, marketed since Apr 2004 and currently FDA-listed.

NDC 00338-0519-13
🏷️ FDA NDC (as labeled) 0338-0519-13 billing pads the labeler segment with a zero
This package
Contains500 mL Medicaid pays$3.31 / unit · 12 mo Per package$1,653.75 / 500 ml · Medicaid Pack sizes5 compare ↓
Also priced by: Part D plans $0.1963/unit — full pricing hub ↓
Product page 00338-0519-14 Also comes in: 100 ml 0338-0519-58 250 ml 0338-0519-09 1000 ml 0338-0519-14 1000 ml 0338-0519-04
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 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 0338-0519-13 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0338 labeler · 0519 product · 13 package
Listing certified through
Dec 31, 2026
Billing quantity
500 mL per package
Barcode (UPC-A, from the NDC)
3 0338051913 2
Medicaid fills, this package
18 prescriptions in the last four reported quarters
FDA record last changed
Oct 2, 2026
Past resolved recalls for this product (2)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1119-2022
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1120-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0338-0519-13
Product NDC 0338-0519
11-digit billing NDC 00338051913
NCPDP billing unit ML — per mL (volume)
RxCUI 200317, 805127, 1799694, 1799696, 1799704, 1799706, 1799724, 1799725
UNII 241ATL177A
Application # NDA018449
SPL Set ID 55609586-f0b4-42e6-8dd9-cd090afb5dca
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 2004-04-01
Route INTRAVENOUS
Dosage form EMULSION
Substance SOYBEAN OIL
TE code (Orange Book) AP · RLD · RS

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

GPI-14 80200010501620
GPI class Intralipid
GCN Seq No 006375
GCN 25211
HICL code 002749
Ingredient (HICL) Fat Emulsions
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 INTRALIPID 20% IV FAT EMUL
FDB brand name Intralipid
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006375
  • GCN: 25211
  • GPI-14 (Medi-Span): 80200010501620
  • HICL (First Databank): 002749
  • AHFS class code: 40:20.00.00
  • RxCUI (RxNorm): 200317
Why two NDCs? The FDA registers this code as 0338-0519-13 — 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 → 00338-0519-13. 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 INTRALIPID 20% IV FAT EMUL Ingredient Fat Emulsions

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 $3.31 $1,653.75 / 500 ml
Medicare drug plans payPart D · Q2 2026 $0.1963 $98.15 / 500 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
00338-0519-14 0338-0519-14 Main listing 1000 mL in 1 BAG 2004-04-01 — Active
00338-0519-04 0338-0519-04 1000 mL in 1 BAG 2004-04-01 — Active
00338-0519-09 0338-0519-09 250 mL in 1 BAG 2004-04-01 — Active
00338-0519-13 You're viewing this 500 mL in 1 BAG 2004-04-01 — Active
00338-0519-58 0338-0519-58 100 mL in 1 BAG 2004-04-01 — Active

This pack accounts for about 11% of this product's recent Medicaid fills; most go to the 1000 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 500 mL — 500 ml in 1 bag.
How does this package differ from NDC 00338-0519-58?
Both are Intralipid I.V. Fat Emulsion 20 g/100mL Emulsion — the drug itself is identical. This page's package is the 500 mL one, while NDC 00338-0519-58 is the 100 ml package.
What NDC number is used to bill for this package of Intralipid I.V. Fat Emulsion 20 g/100mL 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
Intralipid 20 g/100mLthis 00338-0519-13 Baxter 500 ml — AP FDA listed —
Intralipid 20 g/100mL 65219-0531-10 Fresenius 100 ml — AP FDA listed —
Intralipid 20 g/100mL 65219-0535-50 Fresenius 500 ml — AP FDA listed —
Intralipid 20 g/100mL 84549-0533-25 ProPharma 250 ml — AP FDA listed —
Intralipid 20 g/100mL 65219-0539-10 Fresenius 1000 ml — AP FDA listed —
Intralipid 20 g/100mL 84549-0535-50 ProPharma 500 ml — AP FDA listed —
Intralipid 20 g/100mL 65219-0533-25 Fresenius 250 ml — AP 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

🏛️
2004
On the market since
Apr 2004
📍
2026
Currently FDA-listed
22 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

  • 1.2 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.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

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 holderFRESENIUS KABI DEUTSCHLAND GMBH
FDA applicationNDA018449 (NDA)
Labeler code00338
First marketedApr 2004
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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 168 words ▾

WARNINGS Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature 2 . Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment.

Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g fat/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload.

The infant's ability to eliminate the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.

🎯 Indications and Usage 65 words ▾

INDICATIONS AND USAGE Intralipid ® 20% Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrition admixtures (TNAs) to provide a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and a source of essential fatty acids for prevention of EFAD.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Intralipid 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package should be administered only as a part of a three-in-one or total nutrient admixture via peripheral vein or by central venous infusion. Directions For Proper Use of Pharmacy Bulk Package.

INTRALIPID 20% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. The container closure may be penetrated only once using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents to suitable TPN admixture containers must be completed within 4 hours of closure penetration. The bag should be stored below 25°C (77°F) after the closure has been entered. Admixtures made using Intralipid 20% should be used promptly.

See MIXING GUIDELINES AND LIMITATIONS section for admixture storage recommendations. Adult Patients The initial infusion rate of the nutrient admixture in adults should be 0.1 g fat/minute for the first 15 to 30 minutes of infusion. If no untoward reactions occur (see ADVERSE REACTIONS section), the infusion rate can be increased to 0.2 g fat/minute.

For adults, the admixture should not contain more than 500 mL of Intralipid 20% on the first day of therapy. If the patient has no untoward reactions, the dose can be increased on the following day. The daily dosage should not exceed 2.5 g of fat/ kg of body weight (12.5 mL of Intralipid 20% per kg).

Intralipid 20% should make up no more than 60% of the total caloric input to the patient. Maximum infusion rate should not exceed 0.1 g/kg/hr. Carbohydrate and a source of amino acids should comprise the remaining caloric input.

Pediatric Patients The dosage for premature infants starts at 0.5 g fat/kg body weight/24 hours (2.5 mL Intralipid 20%) and may be increased in relation to the infant's ability to eliminate fat. The maximum recommended dosage is 3 g fat/kg/24 hours. Pediatric patients may be at risk for parenteral nutrition-associated liver disease (PNALD), also known as intestinal failure-associated liver disease (see WARNINGS section) when receiving Intralipid for durations exceeding two weeks.

During intravenous administration of Intralipid 20%, perform liver tests to monitor for PNALD. The initial rate of infusion in older pediatric patients should be no more than 0.01 g fat/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.1 g of fat/kg/hour.

The daily dosage should not exceed 3 g of fat/kg of body weight 3 . Intralipid (equivalent to 0.125 g/kg/hour) should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.

Essential Fatty Acid Deficiency When Intralipid 20% is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by Intralipid 20% in order to provide adequate amounts of linoleic and linolenic acids. When EFAD occurs together with stress, the amount of Intralipid 20% needed to correct the deficiency may be increased. Administration See MIXING GUIDELINES AND LIMITATIONS section for information regarding mixing this fat emulsion with other parenteral fluids.

INTRALIPID 20% (A 20% I.V. FAT EMULSION) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. It must be infused as part of an admixture into a central or peripheral vein.

The flow rate of the admixture should be controlled with an infusion pump. Use a 1.2 micron filter with admixtures containing Intralipid 20%. Filters of less than 1.2 micron pore size must not be used.

Conventional administration sets and TPN pooling bags contain polyvinyl chloride (PVC) components that have DEHP (di(2- ethylhexyl) p… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 101 words ▾

CONTRAINDICATIONS Intralipid is contraindicated in patients with: Disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia. Known hypersensitivity to egg, soybean, peanut protein, or to any of the active ingredients or excipients in Intralipid 20%. INTRALIPID 20% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION.

DILUTING INTRALIPID 20% TO A 10% CONCENTRATION WITH INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENTS DOES NOT PRODUCE A DILLITION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID 10% I.V. FAT EMULSION, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS ADMINISTRATION.

🤒 Adverse Reactions 195 words ▾

ADVERSE REACTIONS The adverse reactions observed can be separated into two classes: Those more frequently encountered are due either to a) contamination of the intravenous catheter and result in sepsis, or to b) vein irritation by concurrently infused hypertonic solutions and may result in thrombophlebitis. These adverse reactions are inseparable from the hyperalimentation procedure with or without Intralipid. Less frequent reactions more directly related to Intralipid are: a) immediate or early adverse reactions, each of which has been reported to occur in clinical trials, in an incidence of less than 1%; dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flushing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion, and, rarely, thrombocytopenia in neonates; b) delayed adverse reactions such as hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).

The deposition of a brown pigmentation in the reticuloendothelial system, the so-called “intravenous fat pigment,” has been reported in patients infused with Intralipid . The causes and significance of this phenomenon are unknown.

🤰 Pregnancy 44 words ▾

Pregnancy: Animal reproduction studies have not been conducted with Intralipid. It is also not known whether Intralipid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Intralipid should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 7 words ▾

Pediatric Use: See DOSAGE AND ADMINISTRATION .

🆘 Overdosage 56 words ▾

OVERDOSAGE In the event of fat overload during therapy, stop the infusion of Intralipid 20% (A 20% I.V. Fat Emulsion) until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS .

🧬 Clinical Pharmacology 70 words ▾

CLINICAL PHARMACOLOGY Intralipid is metabolized and utilized as a source of energy causing an increase in heat production, decrease in respiratory quotient and increase in oxygen consumption. The infused fat particles are cleared from the blood stream in a manner thought to be comparable to the clearing of chylomicrons. Intralipid will prevent the biochemical lesions of essential fatty acid deficiency (EFAD) and correct the clinical manifestations of the EFAD syndrome.

📦 How Supplied / Storage and Handling 40 words ▾

HOW SUPPLIED Intralipid 20% is supplied as a sterile emulsion in 1000 mL Pharmacy Bulk Package. 1000 mL NDC 0338-0519-14 Intralipid 20% is also available in the following fill sizes: 100 mL: 0338-0519-58 250 mL: 0338-0519-09 500 mL: 0338 0519-13

📦 Storage and Handling 21 words ▾

STORAGE Intralipid 20% should not be stored above 25°C (77°F). Do not freeze Intralipid 20%. If accidentally frozen, discard the bag.

📋 Description ~2 min read ▾

DESCRIPTION Intralipid ® 20% (A 20% I.V. Fat Emulsion) is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids for use in a pharmacy admixture program. It is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and Water for Injection.

In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. pH range is 6 to 8.9. Intralipid 20% Pharmacy Bulk Package is not intended for direct infusion. It is a sterile dosage form which contains several single doses for use in preparation of three-in-one or total nutrient admixtures (TNAs) in a pharmacy admixture program.

The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: Where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%) 1 . These fatty acids have the following chemical and structural formulas: Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk.

These phospholipids have the following general structure: contain saturated and unsaturated fatty acids that abound in neutral fats. R 3 is primarily either the choline or the ethanolamine ester of phosphoric acid. Glycerin is chemically designated C 3 H 8 O 3 and is a clear colorless, hygroscopic syrupy liquid.

It has the following structural formula: Intralipid 20% (A 20% I.V. Fat Emulsion) has an osmolality of approximately 350 mOsmol/kg water (which represents 260 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. The total caloric value, including fat, phospholipid and glycerin, is 2.0 kcal per mL of Intralipid 20%.

The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion. The primary plastic container (Biofine TM ) is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers.

It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl) phthalate) or PVC. This product is not made with natural rubber latex.

The container is nontoxic and biologically inert. The container-emulsion unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Figure Figure Figure Figure Figure Figure Figure

⚠️ Precautions 174 words ▾

PRECAUTIONS When Intralipid 20% is administered, the patient's capacity to eliminate the infused fat from the circulation must be monitored by use of an appropriate laboratory determination of serum triglycerides. Overdosage must be avoided. During intravenous administration with Intralipid 20%, perform liver tests to monitor for PNALD.

If patients develop liver test abnormalities, consider discontinuation of Intralipid or dosage reduction. (See WARNINGS section). Frequent platelet counts should be done in neonatal patients receiving parenteral nutrition with Intralipid.

Drug product contains no more than 25 mcg/L of aluminum. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Intralipid have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy: Animal reproduction studies have not been conducted with Intralipid.

It is also not known whether Intralipid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Intralipid should be given to a pregnant woman only if clearly needed. Nursing Mothers: Caution should be exercised when Intralipid is administered to a nursing woman.

Pediatric Use: See DOSAGE AND ADMINISTRATION .

🍼 Nursing Mothers 14 words ▾

Nursing Mothers: Caution should be exercised when Intralipid is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 22 words ▾

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

📚 References 88 words ▾

REFERENCES Padley FB: “Major Vegetable Fats”, The Lipid Handbook (Gunstone FD, Harwood JL, Padley FB, eds.), Chapman and Hall Ltd., Cambridge, UK (1986), pp. 88-9. Levene MI, Wigglesworth JS, Desai R: Pulmonary fat accumulation after Intralipid infusion in the preterm infant.

Lancet 1980; 2(8199):815-8. American Academy of Pediatrics: Use of intravenous fat emulsion in pediatric patients. Pediatrics 1981; 68:5(Nov) 738-43.

(Rev May 2022) Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by Fresenius Kabi, Uppsala, Sweden Intralipid ® is a registered trademark of Fresenius Kabi AB.

📖 Instructions for Use 208 words ▾

Instruction for Use - Intralipid ® 20% Pharmacy Bulk Package Container 1. 1. The integrity indicator (Oxalert™) A should be inspected before removing the overwrap.

If the indicator is black the overwrap is damaged and the product should be discarded. 2. 2.

Remove the overwrap by tearing at the notch and pulling down along the container. The Oxalert sachet (A) and the oxygen absorber (B) should be discarded. Place the bag on a clean, flat surface or hang on a support hook.

3. 3. Break off the tamper-evident arrow flag from the blue infusion port.

Use a compounding set with a diameter of 5.6 +/- 0.1 mm. Follow the instructions for use for the compounding set. 4.

4. Hold the base of the infusion port firmly and insert the spike straight through the center of the septum by rotating the wrist slightly if needed. NOTE: Assure that the spike is inserted straight into the port and not at an angle.

Inspect the bag and contents for particulate matter in a well-lit environment prior to use. Discard the bag if there are any signs of discoloration or particulates. 5.

5. Hang the bag in the hanger cut and start transfer to the compounding bag Figure Figure Figure Figure Figure

📄 Package Label / Principal Display Panel 37 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Intralipid 1000 mL Bag Label NDC 0338-0519-14 Intralipid ® 20% A 20% I.V. Fat Emulsion 1000 mL Pharmacy Bulk Package Not for Direct Infusion For Intravenous Use Rx only 20 pbp

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 – Q2 2025 · 2 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
18
Units reimbursed last 4 qtrs
207
Gross reimbursed last 4 qtrs
$684.65
Avg / prescription
$38.04
Avg / unit
$3.3075
Latest quarter Q2 2025
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 18 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported 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: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 207 units · 7.0 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported 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
7.07.0
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 Kansas 7.0 /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 ml00338-0519-14 134 Rx · $19,403
500 ml this page00338-0519-13 18 Rx · $685
250 ml00338-0519-09 13 Rx · $1,699
1000 ml00338-0519-04 No Medicaid data
100 ml00338-0519-58 No Medicaid data
Drug total (last 4 qtrs): 165 Rx · 73,157 units · $21,786 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 Intralipid — 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 Intralipid. 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
$74.9K
Claims incl. refills
179
Beneficiaries
21
Spend / beneficiary
$3,567.72
Spend / claim
$418.56
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 4 other package presentations of this same product, including 100 ml (00338-0519-58), 250 ml (00338-0519-09), 1000 ml (00338-0519-14). 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.
← 00338-0518-12 · Baxter 00338-0520-13 · 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.