Quick answers
- What is Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine used for?
- The FDA-approved label (Aminosyn-PF, ICU Medical Inc., October 17, 2025) says: “Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. …” 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, glycine, histidine, proline, serine, taurine, and tyrosine have a boxed warning?
- The label we quote has no boxed warning, but 1 of 2 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine?
- 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, glycine, histidine, proline, serine, taurine, and tyrosine 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, glycine, histidine, proline, serine, taurine, and tyrosine?
- 1 company lists prescription products of Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine 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, glycine, histidine, proline, serine, taurine, and tyrosine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. …
— FDA label: Aminosyn-PF, ICU Medical Inc., effective October 17, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
The label quoted above has no boxed warning.
1 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Aminosyn-Pf |
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 |
|---|---|---|---|
| NDA019398 AMINOSYN-PF 7% | Otsuka Icu Medcl | September 6, 1985 | 16, latest May 24, 2016 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
| NDA019492 AMINOSYN-PF 10% | Otsuka Icu Medcl | October 17, 1986 | 15, latest October 25, 2002 2002: Manufacturing (CMC) · 2002: Manufacturing (CMC) · 1999: Manufacturing (CMC) |
Shortage status
Current shortage · updated October 16, 2026 · first posted December 8, 2020
| Product | Aminosyn-PF 10%, Injection, 0.1 (NDC 0990-4179-05) |
|---|---|
| Availability | Unavailable |
| Reason given | Shortage of an active ingredient |
| 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) | 800341, 800345, 831426, 831430 |
|---|---|
| SPL set ID of the quoted label | 2d212e10-7e08-4aeb-b63f-dcc927897769 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA019398, NDA019492 |
| Active ingredients (FDA) | ALANINE / ARGININE / ASPARTIC ACID / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / METHIONINE / PHENYLALANINE / PROLINE / SERINE / TAURINE / THREONINE / TRYPTOPHAN / TYROSINE / VALINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aminosyn-PF, ICU Medical Inc., effective October 17, 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 →