FDA.reportPublic FDA data

Aminosyn II

Product NDC
0990-7171
11-digit product format
009907171
Labeler code
0990
Product ID
0990-7171_ea005122-3350-4609-83ad-9d093f25162f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA020041
Marketing category
NDA
Marketing start
2019-11-01
Substance
ACETYL L-TYROSINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE
Active strength
405; 1490; 1527; 1050; 1107; 750; 450; 990; 1500; 1575; 258; 447; 1083; 795; 600; 300; 750 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
Pharmacologic classes
Amino Acid [EPC], Amino Acids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aminosyn II
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETYL L-TYROSINE405 mg/100mL
ALANINE1490 mg/100mL
ARGININE1527 mg/100mL
ASPARTIC ACID1050 mg/100mL
GLUTAMIC ACID1107 mg/100mL
GLYCINE750 mg/100mL
HISTIDINE450 mg/100mL
ISOLEUCINE990 mg/100mL
LEUCINE1500 mg/100mL
LYSINE ACETATE1575 mg/100mL
METHIONINE258 mg/100mL
PHENYLALANINE447 mg/100mL
PROLINE1083 mg/100mL
SERINE795 mg/100mL
THREONINE600 mg/100mL
TRYPTOPHAN300 mg/100mL
VALINE750 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9DLQ4CIU6V, 8DUH1N11BX, OF5P57N2ZX, GMW67QNF9C, 3KX376GY7L, TE7660XO1C, 94ZLA3W45F, 4QD397987E, 30KYC7MIAI, DA8G610ZO5, 47E5O17Y3R, 452VLY9402, TTL6G7LIWZ, AE28F7PNPL, HG18B9YRS7, 2ZD004190S, 04Y7590D77
Rxcui800188, 800192, 800237, 800241

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7171-17Aminosyn II6 in 1 CASEINJECTION, SOLUTION613
0990-7171-17Aminosyn II1 in 1 POUCHINJECTION, SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7171-17ML - Milliliter0990-7171433f55a2-baf4-4671-a7ac-745ec70467df12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7171AMINOSYN 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.]8Current NDC, Legacy NDC, 2 package rows20231129_5b426208-f090-4650-86c3-89040ba45c2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
800241Aminosyn II 10 % Injectable SolutionPSN5b426208-f090-4650-86c3-89040ba45c2d13
800192Aminosyn II 15 % Injectable SolutionPSN5b426208-f090-4650-86c3-89040ba45c2d13
800192alanine 14.9 MG/ML / arginine 15.3 MG/ML / aspartate 10.5 MG/ML / glutamate 11.1 MG/ML / glycine 7.5 MG/ML / histidine 4.5 MG/ML / isoleucine 9.9 MG/ML / leucine 15 MG/ML / lysine 15.8 MG/ML / methionine 2.58 MG/ML / phenylalanine 4.47 MG/ML / proline 10.8 MG/ML / serine 7.95 MG/ML / threonine 6 MG/ML / tryptophan 3 MG/ML / tyrosine 4.05 MG/ML / valine 7.5 MG/ML Injectable Solution [Aminosyn II 15%]SBD5b426208-f090-4650-86c3-89040ba45c2d13
800241alanine 9.93 MG/ML / arginine 10.2 MG/ML / aspartate 7 MG/ML / glutamate 7.38 MG/ML / glycine 5 MG/ML / histidine 3 MG/ML / isoleucine 6.6 MG/ML / leucine 10 MG/ML / lysine 10.5 MG/ML / methionine 1.72 MG/ML / phenylalanine 2.98 MG/ML / proline 7.22 MG/ML / serine 5.3 MG/ML / threonine 4 MG/ML / tryptophan 2 MG/ML / tyrosine 2.7 MG/ML / valine 5 MG/ML Injectable Solution [Aminosyn II 10 %]SBD5b426208-f090-4650-86c3-89040ba45c2d13
800188alanine 14.9 MG/ML / arginine 15.3 MG/ML / aspartate 10.5 MG/ML / glutamate 11.1 MG/ML / glycine 7.5 MG/ML / histidine 4.5 MG/ML / isoleucine 9.9 MG/ML / leucine 15 MG/ML / lysine 15.8 MG/ML / methionine 2.58 MG/ML / phenylalanine 4.47 MG/ML / proline 10.8 MG/ML / serine 7.95 MG/ML / threonine 6 MG/ML / tryptophan 3 MG/ML / tyrosine 4.05 MG/ML / valine 7.5 MG/ML Injectable SolutionSCD5b426208-f090-4650-86c3-89040ba45c2d13
800237alanine 9.93 MG/ML / arginine 10.2 MG/ML / aspartate 7 MG/ML / glutamate 7.38 MG/ML / glycine 5 MG/ML / histidine 3 MG/ML / isoleucine 6.6 MG/ML / leucine 10 MG/ML / lysine 10.5 MG/ML / methionine 1.72 MG/ML / phenylalanine 2.98 MG/ML / proline 7.22 MG/ML / serine 5.3 MG/ML / threonine 4 MG/ML / tryptophan 2 MG/ML / tyrosine 2.7 MG/ML / valine 5 MG/ML Injectable SolutionSCD5b426208-f090-4650-86c3-89040ba45c2d13
800241Aminosyn II 10 % Injectable SolutionSY5b426208-f090-4650-86c3-89040ba45c2d13
800192Aminosyn II 15 % Injectable SolutionSY5b426208-f090-4650-86c3-89040ba45c2d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7171-17009907171176 POUCH in 1 CASE (0990-7171-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG6 pouch2019-11-010000-00-00NoNoCurrent