Quick answers
- What is Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine used for?
- The FDA-approved label (Aminosyn II, ICU Medical Inc., November 2, 2025) says: “Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine have a boxed warning?
- Yes. The FDA label for Aminosyn II has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 16, 2026). Ask your pharmacist about alternatives.
- Has Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine?
- 1 company lists prescription products of Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine in the FDA NDC Directory, including ICU Medical Inc..
What Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. …
— FDA label: Aminosyn II, ICU Medical Inc., effective November 2, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Aminosyn II |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- ICU Medical Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020015 AMINOSYN II 10% IN PLASTIC CONTAINER | Otsuka Icu Medcl | December 19, 1991 | 13, latest September 15, 2014 2014: Manufacturing (CMC) · 2011: Manufacturing (CMC) · 2003: Labeling |
| NDA020041 AMINOSYN II 15% IN PLASTIC CONTAINER | Otsuka Icu Medcl | December 19, 1991 | 12, latest April 27, 2007 2007: Manufacturing (CMC) · 2003: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
Shortage status
Current shortage · updated October 16, 2026 · first posted December 8, 2020
| Product | Aminosyn II 10% In Plastic Container, Injection, 0.1 (NDC 0990-7172-17) |
|---|---|
| Availability | Available |
| Company | Otsuka ICU Medical LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 800188, 800192, 800237, 800241 |
|---|---|
| SPL set ID of the quoted label | 5b426208-f090-4650-86c3-89040ba45c2d |
| FDA labels (SPL) | 1 |
| FDA applications | NDA020015, NDA020041 |
| Active ingredients (FDA) | ACETYL L-TYROSINE / ALANINE / ARGININE / ASPARTIC ACID / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / METHIONINE / PHENYLALANINE / PROLINE / SERINE / THREONINE / TRYPTOPHAN / VALINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aminosyn II, ICU Medical Inc., effective November 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →