NDC 0338-0519
Intralipid
Soybean Oil
Intralipid is a Intravenous Emulsion in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corp. The primary component is Soybean Oil.
| Product ID | 0338-0519_22e62204-57e1-40a1-a23a-89aa0809f9e8 |
| NDC | 0338-0519 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Intralipid |
| Generic Name | Soybean Oil |
| Dosage Form | Emulsion |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2004-04-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020248 |
| Labeler Name | Baxter Healthcare CORP |
| Substance Name | SOYBEAN OIL |
| Active Ingredient Strength | 20 g/100mL |
| Pharm Classes | Lipid Emulsion |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 0338-0519-14
1000 mL in 1 BAG (0338-0519-14)
| Marketing Start Date | 2004-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0338-0519-13 [00338051913]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA018449 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
NDC 0338-0519-04 [00338051904]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA020248 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
NDC 0338-0519-03 [00338051903]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA018449 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
| Marketing End Date | 2015-05-31 |
NDC 0338-0519-48 [00338051948]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA018449 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
| Marketing End Date | 2015-05-31 |
NDC 0338-0519-12 [00338051912]
Intralipid EMULSION
| Marketing Category | UNAPPROVED DRUG OTHER |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-05-30 |
| Marketing End Date | 2015-05-21 |
NDC 0338-0519-11 [00338051911]
Intralipid EMULSION
| Marketing Category | UNAPPROVED DRUG OTHER |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-05-30 |
| Marketing End Date | 2015-05-21 |
NDC 0338-0519-10 [00338051910]
Intralipid EMULSION
| Marketing Category | UNAPPROVED DRUG OTHER |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-05-30 |
| Marketing End Date | 2015-05-21 |
NDC 0338-0519-14 [00338051914]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA020248 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
NDC 0338-0519-09 [00338051909]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA018449 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
NDC 0338-0519-02 [00338051902]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA018449 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
| Marketing End Date | 2015-05-31 |
NDC 0338-0519-58 [00338051958]
Intralipid EMULSION
| Marketing Category | NDA |
| Application Number | NDA018449 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-04-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SOYBEAN OIL | 20 g/100mL |
OpenFDA Data
| SPL SET ID: | 55609586-f0b4-42e6-8dd9-cd090afb5dca |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Lipid Emulsion [EPC]
- Lipids [CS]
- Lipid Emulsion [EPC]
- Lipids [CS]
NDC Crossover Matching brand name "Intralipid" or generic name "Soybean Oil"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0338-0518 | Intralipid | I.V. Fat Emulsion |
| 0338-0519 | Intralipid | SOYBEAN OIL |
| 0338-0520 | Intralipid | SOYBEAN OIL |
| 51662-1333 | INTRALIPID | INTRALIPID |
| 0264-4460 | NutriLipid I.V. Fat Emulsion | Soybean Oil |
Trademark Results [Intralipid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRALIPID 85342969 4403774 Live/Registered |
Kao Kabushiki Kaisha 2011-06-10 |
 INTRALIPID 72168762 0762641 Live/Registered |
Riker Laboratories, Inc. 1963-05-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.