Prescription drug · NDA
Intralipid (I.v. fat emulsion) NDC 65219-539
Soybean oil 20 g/100mL · Emulsion · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-539-10 | 65219053910 | 6 BAG in 1 CASE (65219-539-10) / 1000 mL in 1 BAG (65219-539-01)Marketed from Feb 17, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Intralipid
- Generic name (nonproprietary)
- i.v. fat emulsion
- Active ingredients
- Soybean oil — 20 g/100mL
- Dosage form
- Emulsion
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020248
- Marketing start
- Listing expires
- Other FDA classes
- Lipids (Chemical structure)
- Identifiers
- Product ID 65219-539_18cca00d-c31b-4b61-98ed-6e65c82d3789SPL ID 18cca00d-c31b-4b61-98ed-6e65c82d3789SPL set ID bdcc364b-77b2-4939-8add-03e5396d46c2RxCUI 200317, 805127UNII 241ATL177A
- Pharmacologic class
- Lipid Emulsion
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N465219053910followed by a unit qualifier and the quantityPackage 65219-0539-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Intralipid ® is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD). Intralipid is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).
Excerpt only. Read the full label for complete information.
About NDC 65219-539
- What is NDC 65219-539?
- 65219-539 is the product NDC for Intralipid (i.v. fat emulsion), Soybean oil 20 g/100mL emulsion, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Intralipid (I.V. Fat Emulsion).
- What is the active ingredient?
- Soybean oil.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Intralipid?
- 11 other product NDCs are listed under this name. See all Intralipid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Intralipid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Intralipidi.v. fat emulsion | Soybean oil 10 g/100mL | EmulsionIntravenous | Baxter Healthcare CORP | 0338-0518 | 00338-0518-1200338-0518-1300338-0518-58 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Baxter Healthcare Corporation | 0338-0519 | 00338-0519-14 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Baxter Healthcare Corporation | 0338-0519 | 00338-0519-04 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Baxter Healthcare Corporation | 0338-0519 | 00338-0519-0900338-0519-1300338-0519-58 |
| Intralipidi. v. fat emulsion | Soybean oil 30 g/100mL | EmulsionIntravenous | Baxter Healthcare Corporation | 0338-0520 | 00338-0520-13 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Fresenius Kabi USA, LLC | 65219-531 | 65219-0531-10 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Fresenius Kabi USA, LLC | 65219-533 | 65219-0533-25 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Fresenius Kabi USA, LLC | 65219-535 | 65219-0535-50 |
| Intralipidi.v. fat emulsion | Soybean oil 30 g/100mL | EmulsionIntravenous | Fresenius Kabi USA, LLC | 65219-537 | 65219-0537-50 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | ProPharma Distribution | 84549-533 | 84549-0533-25 |
Other NDCs under NDA 020248
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Baxter Healthcare Corporation | 0338-0519 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | Baxter Healthcare Corporation | 0338-0519 |