United States· US:0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49
Aminosyn-PF
A amino acids product containing isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine, registered in United States by ICU Medical Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE
- Manufacturer
- ICU Medical Inc.
- Country
- United States (US)
- ATC code
- B05XB
- ATC class
- Amino acids
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 1
- ndc11099041780312 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG
Regulatory notes
Same class
Other records under B05XB
Amino acids, as other registers publish it.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/8db15342-af71-4d65-bb94-30fa56864032 GET /v1/drugs/8db15342-af71-4d65-bb94-30fa56864032?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"unii": {
"unii": "OF5P57N2ZX",
"rxcui": "426",
"inchikey": "QNAYBMKLOCPYGJ-REOHCLBHSA-N",
"display_name": "ALANINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"46e74ce4-cd7e-437f-bf54-ca9b98eb2663": {
"match": "brand_token",
"title": "AMINOSYN-PF (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
"spl_version": "12",
"published_date": "2025-11-17"
}
},
"productid": "0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49",
"productndc": "0990-4178",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "019398",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "7% (7GM/100ML)",
"product_no": "001",
"approval_date": "Sep 6, 1985"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"proprietary_name": "Aminosyn-PF",
"active_ingred_unit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"application_number": "NDA019398",
"marketing_category": "NDA",
"nonproprietary_name": "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE",
"start_marketing_date": "20211001",
"active_numerator_strength": "490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452"
}See everything about isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.