NDC codes

FDA NDC Directory
Product NDC (as listed)0338-9540Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-9540Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0338-9540-050033895400515 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01)Marketed from Jan 1, 2016
0338-9540-060033895400610 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02)Marketed from Jan 1, 2016
0338-9540-070033895400712 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03)Marketed from Jan 1, 2016
0338-9540-08003389540086 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.

How CPT relates to drug billing

NDC on a medical claim

N400338954005 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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