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 405 mg/100mL, alanine 1490 mg/100mL, arginine 1527 mg/100mL, aspartic acid 1050 mg/100mL, glutamic acid 1107 mg/100mL, glycine 750 mg/100mL, histidine 450 mg/100mL, isoleucine 990 mg/100mL, leucine 1500 mg/100mL, lysine acetate 1575 mg/100mL, methionine 258 mg/100mL, phenylalanine 447 mg/100mL, proline 1083 mg/100mL, serine 795 mg/100mL, threonine 600 mg/100mL, tryptophan 300 mg/100mL, valine 750 mg/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-7171
Product ID 0990-7171_ea005122-3350-4609-83ad-9d093f25162f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020041
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 09907171
Hyphenated Format 0990-7171

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 NDA020041 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 405 mg/100mL
  • 1490 mg/100mL
  • 1527 mg/100mL
  • 1050 mg/100mL
  • 1107 mg/100mL
  • 750 mg/100mL
  • 450 mg/100mL
  • 990 mg/100mL
  • 1500 mg/100mL
  • 1575 mg/100mL
  • 258 mg/100mL
  • 447 mg/100mL
  • 1083 mg/100mL
  • 795 mg/100mL
  • 600 mg/100mL
  • 300 mg/100mL
source: ndc
Packaging
  • 6 POUCH in 1 CASE (0990-7171-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG
source: ndc

Packages (1)

0990-7171-17 6 POUCH in 1 CASE (0990-7171-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG

Ingredients (17)

acetyl l-tyrosine (405 mg/100mL) alanine (1490 mg/100mL) arginine (1527 mg/100mL) aspartic acid (1050 mg/100mL) glutamic acid (1107 mg/100mL) glycine (750 mg/100mL) histidine (450 mg/100mL) isoleucine (990 mg/100mL) leucine (1500 mg/100mL) lysine acetate (1575 mg/100mL) methionine (258 mg/100mL) phenylalanine (447 mg/100mL) proline (1083 mg/100mL) serine (795 mg/100mL) threonine (600 mg/100mL) tryptophan (300 mg/100mL) valine (750 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 (0990-7171-17)  / 1 BAG in 1 POUCH / 2000 mL in 1 BAG", "package_ndc": "0990-7171-17", "marketing_start_date": "20191101"}], "brand_name": "Aminosyn II", "product_id": "0990-7171_ea005122-3350-4609-83ad-9d093f25162f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0990-7171", "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": "405 mg/100mL"}, {"name": "ALANINE", "strength": "1490 mg/100mL"}, {"name": "ARGININE", "strength": "1527 mg/100mL"}, {"name": "ASPARTIC ACID", "strength": "1050 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "1107 mg/100mL"}, {"name": "GLYCINE", "strength": "750 mg/100mL"}, {"name": "HISTIDINE", "strength": "450 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "990 mg/100mL"}, {"name": "LEUCINE", "strength": "1500 mg/100mL"}, {"name": "LYSINE ACETATE", "strength": "1575 mg/100mL"}, {"name": "METHIONINE", "strength": "258 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "447 mg/100mL"}, {"name": "PROLINE", "strength": "1083 mg/100mL"}, {"name": "SERINE", "strength": "795 mg/100mL"}, {"name": "THREONINE", "strength": "600 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "300 mg/100mL"}, {"name": "VALINE", "strength": "750 mg/100mL"}], "application_number": "NDA020041", "marketing_category": "NDA", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}