Prescription medicine
Alanine, arginine and 17 other ingredients Brand names: Premasol
Alanine, arginine and 17 other ingredients (Premasol) is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the alanine, arginine and 17 other ingredients FDA label on DailyMed (effective August 4, 2022); every alanine, arginine and 17 other ingredients label on DailyMed.
Highlights of the record
FDA label of August 4, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Pharmacy Bulk Package Not for Direct Infusion
Used for
From the label: indications and usagePREMASOL 10% injection 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.
Forms and strengths
- 1.4 g/100ml / 0.82 g/100ml / 0.82 g/100ml / 0.78 g/100ml / 0.48 g/100ml / 0.48 g/100ml / 0.42 g/100ml / 0.34 g/100ml / 0.2 g/100ml / 0.24 g/100ml / 1.2 g/100ml / 0.68 g/100ml / 0.54 g/100ml / 0.5 g/100ml / 0.38 g/100ml / 0.36 g/100ml / 0.32 g/100ml / 25 mg/100ml / 0.016 g/100ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 59 through July 30, 2026
What is alanine, arginine and 17 other ingredients used for?
From the label: indications and usagePREMASOL 10% injection 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. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. […]
FDA pharmacologic class: Amino Acid.
Source: FDA drug label (Premasol - sulfite-free (Amino Acid)), Baxter Healthcare Company, effective August 4, 2022 (SPL set 9afdcc3e-0d06-47f4-86ca-40da48b2b02b), via openFDA; the full label on DailyMed
Is there a generic for alanine, arginine and 17 other ingredients (Premasol)?
No generic alanine, arginine and 17 other ingredients is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists alanine, arginine and 17 other ingredients from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is alanine, arginine and 17 other ingredients in shortage?
No alanine, arginine and 17 other ingredients presentation is listed as limited or unavailable in the FDA Drug Shortage Database (read October 8, 2026); it keeps 3 current entries listed as available (updated October 2, 2026). ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-03) | Baxter Healthcare | Current | October 2, 2026 |
| Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-04) | Baxter Healthcare | Current | October 2, 2026 |
| Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-06) | Baxter Healthcare | Current | October 2, 2026 |
Every alanine, arginine and 17 other ingredients presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What do FAERS reports show for alanine, arginine and 17 other ingredients?
The FDA Adverse Event Reporting System holds 59 reports that list alanine, arginine and 17 other ingredients among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 27 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other amino acids
- the pharmacologic class, with prices and generics
- Alanine, arginine and 17 other ingredients side effects
- the label's list beside FAERS reports
- Alanine, arginine and 17 other ingredients shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other