NDC 63323-820
Smoflipid
Smoflipid
Smoflipid is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Soybean Oil; Me.
| Product ID | 63323-820_3f7384e8-3154-4d8f-a153-831a34f29852 |
| NDC | 63323-820 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Smoflipid |
| Generic Name | Smoflipid |
| Dosage Form | Injection, Emulsion |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2016-07-13 |
| Marketing Category | NDA / NDA |
| Application Number | NDA207648 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | SOYBEAN OIL; ME |
| Active Ingredient Strength | 6 g/100mL; g/100m |
| Pharm Classes | Lipid Emulsion |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 63323-820-00
10 BAG in 1 CASE (63323-820-00) > 100 mL in 1 BAG (63323-820-01)
| Marketing Start Date | 2016-07-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 63323-820-12 [63323082012]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-13 |
NDC 63323-820-02 [63323082002]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-04-12 |
NDC 63323-820-10 [63323082010]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-05-27 |
NDC 63323-820-74 [63323082074]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-07-13 |
NDC 63323-820-03 [63323082003]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-04-12 |
NDC 63323-820-04 [63323082004]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-04-12 |
NDC 63323-820-01 [63323082001]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-04-12 |
NDC 63323-820-05 [63323082005]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-04-25 |
NDC 63323-820-00 [63323082000]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-07-13 |
NDC 63323-820-50 [63323082050]
Smoflipid INJECTION, EMULSION
| Marketing Category | NDA |
| Application Number | NDA207648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-07-13 |
Drug Details
Pharmacological Class
- Lipid Emulsion [EPC]
- Lipids [CS]
- Lipid Emulsion [EPC]
- Lipids [CS]
Trademark Results [Smoflipid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMOFLIPID 86103117 4809212 Live/Registered |
Fresenius Kabi AG 2013-10-28 |
 SMOFLIPID 78771379 3324015 Dead/Cancelled |
Fresenius Kabi AG 2005-12-12 |
 SMOFLIPID 76141824 not registered Dead/Abandoned |
Fresenius Kabi AG 2000-10-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.