Prescription drug · NDA
Intralipid (I.v. fat emulsion) NDC 0338-0518
Soybean oil 10 g/100mL · Emulsion · Intravenous · Baxter Healthcare CORP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0518-12 | 00338051812 | 250 mL in 1 BAG (0338-0518-12)Marketed from Dec 12, 2014 | |
| 0338-0518-13 | 00338051813 | 500 mL in 1 BAG (0338-0518-13)Marketed from Dec 12, 2014 | |
| 0338-0518-58 | 00338051858 | 100 mL in 1 BAG (0338-0518-58)Marketed from Dec 12, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 g/100mL
- Dosage form
- Emulsion
- Route
- Intravenous
- Labeler
- Baxter Healthcare CORPNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017643
- Marketing start
- Listing expires
- Other FDA classes
- Lipids (Chemical structure)
- Identifiers
- Product ID 0338-0518_3044bcdc-50b3-437a-ad5e-6871defe1676SPL ID 3044bcdc-50b3-437a-ad5e-6871defe1676SPL set ID 069460a5-3e9a-428f-b2dc-3405690f4fd7RxCUI 1859368, 1859370, 1859372, 1859373, 1859374, 1859375UNII 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
N400338051812followed by a unit qualifier and the quantityPackage 00338-0518-12. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Intralipid ® 10% is indicated as 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 as a source of essential fatty acids for prevention of EFAD.
Excerpt only. Read the full label for complete information.
About NDC 0338-0518
- What is NDC 0338-0518?
- 0338-0518 is the product NDC for Intralipid (i.v. fat emulsion), Soybean oil 10 g/100mL emulsion, listed with the FDA by Baxter Healthcare CORP. It has 3 package NDCs, 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?
- Baxter Healthcare CORP, NDC labeler code 0338. 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 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 | Fresenius Kabi USA, LLC | 65219-539 | 65219-0539-10 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | ProPharma Distribution | 84549-533 | 84549-0533-25 |
| Intralipidi.v. fat emulsion | Soybean oil 20 g/100mL | EmulsionIntravenous | ProPharma Distribution | 84549-535 | 84549-0535-50 |
| 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 |