aminosyn ii

Generic: isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine

Labeler: icu medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aminosyn ii
Generic Name isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine
Labeler icu medical inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetyl l-tyrosine 270 mg/100mL, alanine 993 mg/100mL, arginine 1018 mg/100mL, aspartic acid 700 mg/100mL, glutamic acid 738 mg/100mL, glycine 500 mg/100mL, histidine 300 mg/100mL, isoleucine 660 mg/100mL, leucine 1000 mg/100mL, lysine acetate 1050 mg/100mL, methionine 172 mg/100mL, phenylalanine 298 mg/100mL, proline 722 mg/100mL, serine 530 mg/100mL, threonine 400 mg/100mL, tryptophan 200 mg/100mL, valine 500 mg/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-7172
Product ID 0990-7172_ea005122-3350-4609-83ad-9d093f25162f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020015
Listing Expiration 2026-12-31
Marketing Start 2019-11-01

Pharmacologic Class

Established (EPC)
amino acid [epc]
Chemical Structure
amino acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09907172
Hyphenated Format 0990-7172

Supplemental Identifiers

RxCUI
800188 800192 800237 800241
UNII
HG18B9YRS7 AE28F7PNPL OF5P57N2ZX 04Y7590D77 DA8G610ZO5 30KYC7MIAI TTL6G7LIWZ 452VLY9402 3KX376GY7L 94ZLA3W45F 8DUH1N11BX TE7660XO1C 2ZD004190S 4QD397987E GMW67QNF9C 9DLQ4CIU6V 47E5O17Y3R
NUI
N0000175780 M0000922

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name aminosyn ii (source: ndc)
Generic Name isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine, and glycine (source: ndc)
Application Number NDA020015 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 270 mg/100mL
  • 993 mg/100mL
  • 1018 mg/100mL
  • 700 mg/100mL
  • 738 mg/100mL
  • 500 mg/100mL
  • 300 mg/100mL
  • 660 mg/100mL
  • 1000 mg/100mL
  • 1050 mg/100mL
  • 172 mg/100mL
  • 298 mg/100mL
  • 722 mg/100mL
  • 530 mg/100mL
  • 400 mg/100mL
  • 200 mg/100mL
source: ndc
Packaging
  • 6 POUCH in 1 CASE (0990-7172-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG
source: ndc

Packages (1)

0990-7172-17 6 POUCH in 1 CASE (0990-7172-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG

Ingredients (17)

acetyl l-tyrosine (270 mg/100mL) alanine (993 mg/100mL) arginine (1018 mg/100mL) aspartic acid (700 mg/100mL) glutamic acid (738 mg/100mL) glycine (500 mg/100mL) histidine (300 mg/100mL) isoleucine (660 mg/100mL) leucine (1000 mg/100mL) lysine acetate (1050 mg/100mL) methionine (172 mg/100mL) phenylalanine (298 mg/100mL) proline (722 mg/100mL) serine (530 mg/100mL) threonine (400 mg/100mL) tryptophan (200 mg/100mL) valine (500 mg/100mL)

Linked Drug Pages (1)

Aminosyn II ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea005122-3350-4609-83ad-9d093f25162f", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["HG18B9YRS7", "AE28F7PNPL", "OF5P57N2ZX", "04Y7590D77", "DA8G610ZO5", "30KYC7MIAI", "TTL6G7LIWZ", "452VLY9402", "3KX376GY7L", "94ZLA3W45F", "8DUH1N11BX", "TE7660XO1C", "2ZD004190S", "4QD397987E", "GMW67QNF9C", "9DLQ4CIU6V", "47E5O17Y3R"], "rxcui": ["800188", "800192", "800237", "800241"], "spl_set_id": ["5b426208-f090-4650-86c3-89040ba45c2d"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["ICU Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CASE (0990-7172-17)  / 1 BAG in 1 POUCH / 2000 mL in 1 BAG", "package_ndc": "0990-7172-17", "marketing_start_date": "20191101"}], "brand_name": "Aminosyn II", "product_id": "0990-7172_ea005122-3350-4609-83ad-9d093f25162f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0990-7172", "generic_name": "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminosyn II", "active_ingredients": [{"name": "ACETYL L-TYROSINE", "strength": "270 mg/100mL"}, {"name": "ALANINE", "strength": "993 mg/100mL"}, {"name": "ARGININE", "strength": "1018 mg/100mL"}, {"name": "ASPARTIC ACID", "strength": "700 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "738 mg/100mL"}, {"name": "GLYCINE", "strength": "500 mg/100mL"}, {"name": "HISTIDINE", "strength": "300 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "660 mg/100mL"}, {"name": "LEUCINE", "strength": "1000 mg/100mL"}, {"name": "LYSINE ACETATE", "strength": "1050 mg/100mL"}, {"name": "METHIONINE", "strength": "172 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "298 mg/100mL"}, {"name": "PROLINE", "strength": "722 mg/100mL"}, {"name": "SERINE", "strength": "530 mg/100mL"}, {"name": "THREONINE", "strength": "400 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "200 mg/100mL"}, {"name": "VALINE", "strength": "500 mg/100mL"}], "application_number": "NDA020015", "marketing_category": "NDA", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}