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 698 mg/100mL, arginine 1227 mg/100mL, aspartic acid 527 mg/100mL, glutamic acid 820 mg/100mL, glycine 385 mg/100mL, histidine 312 mg/100mL, isoleucine 760 mg/100mL, leucine 1200 mg/100mL, lysine acetate 677 mg/100mL, methionine 180 mg/100mL, phenylalanine 427 mg/100mL, proline 812 mg/100mL, serine 495 mg/100mL, taurine 70 mg/100mL, threonine 512 mg/100mL, tryptophan 180 mg/100mL, tyrosine 44 mg/100mL, valine 673 mg/100mL

Manufacturer
ICU Medical Inc.

Identifiers & Regulatory

Product NDC 0990-4179
Product ID 0990-4179_2d8f2280-bc20-45ba-bdf3-12c055684017
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019492
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 09904179
Hyphenated Format 0990-4179

Supplemental Identifiers

RxCUI
800341 800345
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 NDA019492 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 698 mg/100mL
  • 1227 mg/100mL
  • 527 mg/100mL
  • 820 mg/100mL
  • 385 mg/100mL
  • 312 mg/100mL
  • 760 mg/100mL
  • 1200 mg/100mL
  • 677 mg/100mL
  • 180 mg/100mL
  • 427 mg/100mL
  • 812 mg/100mL
  • 495 mg/100mL
  • 70 mg/100mL
  • 512 mg/100mL
  • 44 mg/100mL
  • 673 mg/100mL
source: ndc
Packaging
  • 6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG
source: ndc

Packages (1)

0990-4179-05 6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG

Ingredients (18)

alanine (698 mg/100mL) arginine (1227 mg/100mL) aspartic acid (527 mg/100mL) glutamic acid (820 mg/100mL) glycine (385 mg/100mL) histidine (312 mg/100mL) isoleucine (760 mg/100mL) leucine (1200 mg/100mL) lysine acetate (677 mg/100mL) methionine (180 mg/100mL) phenylalanine (427 mg/100mL) proline (812 mg/100mL) serine (495 mg/100mL) taurine (70 mg/100mL) threonine (512 mg/100mL) tryptophan (180 mg/100mL) tyrosine (44 mg/100mL) valine (673 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": "2d8f2280-bc20-45ba-bdf3-12c055684017", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "TTL6G7LIWZ", "AE28F7PNPL", "47E5O17Y3R", "9DLQ4CIU6V", "452VLY9402", "1EQV5MLY3D", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "rxcui": ["800341", "800345"], "spl_set_id": ["46e74ce4-cd7e-437f-bf54-ca9b98eb2663"], "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 BAG in 1 CASE (0990-4179-05)  / 1000 mL in 1 BAG", "package_ndc": "0990-4179-05", "marketing_start_date": "20191101"}], "brand_name": "Aminosyn-PF", "product_id": "0990-4179_2d8f2280-bc20-45ba-bdf3-12c055684017", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]"], "product_ndc": "0990-4179", "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": "698 mg/100mL"}, {"name": "ARGININE", "strength": "1227 mg/100mL"}, {"name": "ASPARTIC ACID", "strength": "527 mg/100mL"}, {"name": "GLUTAMIC ACID", "strength": "820 mg/100mL"}, {"name": "GLYCINE", "strength": "385 mg/100mL"}, {"name": "HISTIDINE", "strength": "312 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "760 mg/100mL"}, {"name": "LEUCINE", "strength": "1200 mg/100mL"}, {"name": "LYSINE ACETATE", "strength": "677 mg/100mL"}, {"name": "METHIONINE", "strength": "180 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "427 mg/100mL"}, {"name": "PROLINE", "strength": "812 mg/100mL"}, {"name": "SERINE", "strength": "495 mg/100mL"}, {"name": "TAURINE", "strength": "70 mg/100mL"}, {"name": "THREONINE", "strength": "512 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "180 mg/100mL"}, {"name": "TYROSINE", "strength": "44 mg/100mL"}, {"name": "VALINE", "strength": "673 mg/100mL"}], "application_number": "NDA019492", "marketing_category": "NDA", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}