Prescription drug · NDA
Clinolipid (Olive oil and soybean oil) NDC 0338-9540
Olive oil 16 g/100mL; Soybean oil 4 g/100mL · Injection, Emulsion · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-9540-05 | 00338954005 | 15 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01)Marketed from Jan 1, 2016 | |
| 0338-9540-06 | 00338954006 | 10 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02)Marketed from Jan 1, 2016 | |
| 0338-9540-07 | 00338954007 | 12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03)Marketed from Jan 1, 2016 | |
| 0338-9540-08 | 00338954008 | 6 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04)Marketed from Jan 1, 2016 |
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)
- Clinolipid
- Generic name (nonproprietary)
- olive oil and soybean oil
- Active ingredients
- Olive oil — 16 g/100mLSoybean oil — 4 g/100mL
- Dosage form
- Injection, Emulsion
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204508
- Marketing start
- Listing expires
- Other FDA classes
- Lipids (Chemical structure)Lipids (Chemical structure)
- Identifiers
- Product ID 0338-9540_548f8a90-9826-4750-8e46-d763bd586bf2SPL ID 548f8a90-9826-4750-8e46-d763bd586bf2SPL set ID ae98eb03-c0e7-49d1-b024-77968e3d9d6eRxCUI 1986373, 1986378, 1986381, 1986382, 1986385, 1986386, 1986388, 1986389UNII 6UYK2W1W1E, 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
N400338954005followed by a unit qualifier and the quantityPackage 00338-9540-05. 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)
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 )
Excerpt only. Read the full label for complete information.
About NDC 0338-9540
- What is NDC 0338-9540?
- 0338-9540 is the product NDC for Clinolipid, Olive oil 16 g/100mL; Soybean oil 4 g/100mL injection, emulsion, listed with the FDA by Baxter Healthcare Corporation. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clinolipid (Olive Oil and Soybean Oil).
- What is the active ingredient?
- Olive oil, Soybean oil.
- Who is the labeler?
- Baxter Healthcare Corporation, 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 Clinolipid?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.