Quick answers
- What is Kabiven?
- Kabiven is a brand name of Dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine, a prescription medicine. The FDA NDC Directory lists 1 Kabiven product in 1 strength and form.
- Who makes Kabiven?
- Fresenius Kabi USA holds the FDA application for Kabiven (NDA200656, approved August 25, 2014).
- Is there a generic or store brand of Kabiven?
- Other products of Dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine are listed with the FDA, but none in exactly the same strength and form as a Kabiven product.
- Has Kabiven been recalled?
- FDA enforcement reports list 1 recall of Kabiven products; the newest started April 28, 2015. A recall usually concerns specific lots, not every product.
What Kabiven is
Each Kabiven product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| alanine 467 mg/100 mL · arginine 330 mg/100 mL · aspartic acid 99 mg/100 mL · calcium chloride 29 mg/100 mL · dextrose monohydrate 10.8% · glutamic acid 164 mg/100 mL · glycine 231 mg/100 mL · histidine 199 mg/100 mL · isoleucine 164 mg/100 mL · leucine 231 mg/100 mL · lysine hydrochloride 263 mg/100 mL · magnesium sulfate heptahydrate 96 mg/100 mL · methionine 164 mg/100 mL · phenylalanine 231 mg/100 mL · potassium chloride 174 mg/100 mL · proline 199 mg/100 mL · serine 131 mg/100 mL · sodium acetate 239 mg/100 mL · sodium glycerophosphate anhydrous 147 mg/100 mL · soybean oil 3.9% · threonine 164 mg/100 mL · tryptophan 55 mg/100 mL · tyrosine 6.7 mg/100 mL · valine 213 mg/100 mL injection, emulsion (intravenous) | Kabiven | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA200656 | Fresenius Kabi USA | August 25, 2014 | 1 |
Companies that list Kabiven
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Kabiven products.
- Fresenius Kabi USA, LLC1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 28, 2015 · Class II · Terminated · D-1114-2015
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-71 — Fresenius Kabi USA, LLC
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.