🇺🇸
United States · US · US:0990-7172_ea005122-3350-4609-83ad-9d093f25162f
Aminosyn II
Orange BookUNIISPLATC B05XB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerICU Medical Inc.
CountryUS (United States)
ATC codeB05XB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1109907172176 POUCH in 1 CASE (0990-7172-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
DA8G610ZO5
ACETYL L-TYROSINE
RxCUI 31005
Orange Book
N020015
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "DA8G610ZO5",
"rxcui": "31005",
"inchikey": "CAHKINHBCWCHCF-JTQLQIEISA-N",
"display_name": "ACETYL L-TYROSINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5b426208-f090-4650-86c3-89040ba45c2d": {
"match": "brand_token",
"title": "AMINOSYN II (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
"spl_version": "13",
"published_date": "2025-11-17"
}
},
"productid": "0990-7172_ea005122-3350-4609-83ad-9d093f25162f",
"productndc": "0990-7172",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "020015",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10% (10GM/100ML)",
"product_no": "001",
"approval_date": "Dec 19, 1991"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETYL L-TYROSINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE",
"proprietary_name": "Aminosyn II",
"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",
"application_number": "NDA020015",
"marketing_category": "NDA",
"nonproprietary_name": "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE",
"start_marketing_date": "20191101",
"active_numerator_strength": "270; 993; 1018; 700; 738; 500; 300; 660; 1000; 1050; 172; 298; 722; 530; 400; 200; 500"
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