aminosyn-pf

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

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

Drug Facts

Product Profile

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

alanine 490 mg/100mL, arginine 861 mg/100mL, aspartic acid 370 mg/100mL, glutamic acid 576 mg/100mL, glycine 270 mg/100mL, histidine 220 mg/100mL, isoleucine 534 mg/100mL, leucine 831 mg/100mL, lysine acetate 475 mg/100mL, methionine 125 mg/100mL, phenylalanine 300 mg/100mL, proline 570 mg/100mL, serine 347 mg/100mL, taurine 50 mg/100mL, threonine 360 mg/100mL, tryptophan 125 mg/100mL, tyrosine 44 mg/100mL, valine 452 mg/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-4178
Product ID 0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019398
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09904178
Hyphenated Format 0990-4178

Supplemental Identifiers

RxCUI
831426 831430
UNII
OF5P57N2ZX 94ZLA3W45F 30KYC7MIAI 3KX376GY7L TE7660XO1C 4QD397987E 04Y7590D77 GMW67QNF9C TTL6G7LIWZ AE28F7PNPL 47E5O17Y3R 9DLQ4CIU6V 452VLY9402 1EQV5MLY3D 2ZD004190S 8DUH1N11BX 42HK56048U HG18B9YRS7
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-pf (source: ndc)
Generic Name isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine (source: ndc)
Application Number NDA019398 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 490 mg/100mL
  • 861 mg/100mL
  • 370 mg/100mL
  • 576 mg/100mL
  • 270 mg/100mL
  • 220 mg/100mL
  • 534 mg/100mL
  • 831 mg/100mL
  • 475 mg/100mL
  • 125 mg/100mL
  • 300 mg/100mL
  • 570 mg/100mL
  • 347 mg/100mL
  • 50 mg/100mL
  • 360 mg/100mL
  • 44 mg/100mL
  • 452 mg/100mL
source: ndc
Packaging
  • 12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG
source: ndc

Packages (1)

0990-4178-03 12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG

Ingredients (18)

alanine (490 mg/100mL) arginine (861 mg/100mL) aspartic acid (370 mg/100mL) glutamic acid (576 mg/100mL) glycine (270 mg/100mL) histidine (220 mg/100mL) isoleucine (534 mg/100mL) leucine (831 mg/100mL) lysine acetate (475 mg/100mL) methionine (125 mg/100mL) phenylalanine (300 mg/100mL) proline (570 mg/100mL) serine (347 mg/100mL) taurine (50 mg/100mL) threonine (360 mg/100mL) tryptophan (125 mg/100mL) tyrosine (44 mg/100mL) valine (452 mg/100mL)

Linked Drug Pages (1)

Aminosyn-PF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "488d78ac-3cd2-4593-8968-2992fe59bb49", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "1EQV5MLY3D", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["831426", "831430"], "spl_set_id": ["2d212e10-7e08-4aeb-b63f-dcc927897769"], "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": "12 BAG in 1 CASE (0990-4178-03)  / 500 mL in 1 BAG", "package_ndc": "0990-4178-03", "marketing_start_date": "20211001"}], "brand_name": "Aminosyn-PF", "product_id": "0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0990-4178", "generic_name": "ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE", "labeler_name": "ICU Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aminosyn-PF", "active_ingredients": [{"name": "ALANINE", "strength": "490 mg/100mL"}, {"name": "ARGININE", "strength": "861 mg/100mL"}, {"name": "ASPARTIC ACID", "strength": "370 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "576 mg/100mL"}, {"name": "GLYCINE", "strength": "270 mg/100mL"}, {"name": "HISTIDINE", "strength": "220 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "534 mg/100mL"}, {"name": "LEUCINE", "strength": "831 mg/100mL"}, {"name": "LYSINE ACETATE", "strength": "475 mg/100mL"}, {"name": "METHIONINE", "strength": "125 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "300 mg/100mL"}, {"name": "PROLINE", "strength": "570 mg/100mL"}, {"name": "SERINE", "strength": "347 mg/100mL"}, {"name": "TAURINE", "strength": "50 mg/100mL"}, {"name": "THREONINE", "strength": "360 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "125 mg/100mL"}, {"name": "TYROSINE", "strength": "44 mg/100mL"}, {"name": "VALINE", "strength": "452 mg/100mL"}], "application_number": "NDA019398", "marketing_category": "NDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}