FDA Orange Book
Is there a generic for Smoflipid?
Smoflipid contains fish oil, medium chain triglycerides, olive oil and soybean oil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Smoflipid (fish oil, medium chain triglycerides, olive oil and soybean oil).
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Smoflipid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, intravenous | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) | Marketed (Rx) | None | 0 | None |
| emulsion, intravenous | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) | Marketed (Rx) | None | 0 | None |
| emulsion, intravenous | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) | Marketed (Rx) | None | 0 | None |
| emulsion, intravenous | 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) | Marketed (Rx) | None | 0 | None |
NDA 207648, held by FRESENIUS KABI USA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Smoflipid NDC codes
Questions
Is there a generic for Smoflipid?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Smoflipid (fish oil, medium chain triglycerides, olive oil and soybean oil).
What is the generic name for Smoflipid?
The active ingredient in Smoflipid is fish oil, medium chain triglycerides, olive oil and soybean oil, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.