FDA.reportPublic FDA data

Aminosyn-PF

Product NDC
0990-4178
11-digit product format
009904178
Labeler code
0990
Product ID
0990-4178_488d78ac-3cd2-4593-8968-2992fe59bb49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA019398
Marketing category
NDA
Marketing start
2021-10-01
Substance
ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Active strength
490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452 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; 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-PF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALANINE490 mg/100mL
ARGININE861 mg/100mL
ASPARTIC ACID370 mg/100mL
GLUTAMIC ACID576 mg/100mL
GLYCINE270 mg/100mL
HISTIDINE220 mg/100mL
ISOLEUCINE534 mg/100mL
LEUCINE831 mg/100mL
LYSINE ACETATE475 mg/100mL
METHIONINE125 mg/100mL
PHENYLALANINE300 mg/100mL
PROLINE570 mg/100mL
SERINE347 mg/100mL
TAURINE50 mg/100mL
THREONINE360 mg/100mL
TRYPTOPHAN125 mg/100mL
TYROSINE44 mg/100mL
VALINE452 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOF5P57N2ZX, 94ZLA3W45F, 30KYC7MIAI, 3KX376GY7L, TE7660XO1C, 4QD397987E, 04Y7590D77, GMW67QNF9C, TTL6G7LIWZ, AE28F7PNPL, 47E5O17Y3R, 9DLQ4CIU6V, 452VLY9402, 1EQV5MLY3D, 2ZD004190S, 8DUH1N11BX, 42HK56048U, HG18B9YRS7
Rxcui831426, 831430

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
0990-4178-03Aminosyn-PF500 mL in 1 BAGINJECTION, SOLUTION5004
0990-4178-03Aminosyn-PF12 in 1 CASEINJECTION, SOLUTION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-4178-03ML - Milliliter0990-417851ef26ce-b92f-4292-ac71-7433a4ccc6ee12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-4178AMINOSYN-PF (ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE) INJECTION, SOLUTION [ICU MEDICAL INC.]3Current NDC, Legacy NDC, 2 package rows20231129_2d212e10-7e08-4aeb-b63f-dcc927897769.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831430Aminosyn-PF 7 % Injectable SolutionPSN2d212e10-7e08-4aeb-b63f-dcc9278977694
831430alanine 4.9 MG/ML / arginine 8.61 MG/ML / aspartate 3.7 MG/ML / glutamate 5.76 MG/ML / glycine 2.7 MG/ML / histidine 2.2 MG/ML / isoleucine 5.34 MG/ML / leucine 8.31 MG/ML / lysine 4.75 MG/ML / methionine 1.25 MG/ML / phenylalanine 3 MG/ML / proline 5.7 MG/ML / serine 3.47 MG/ML / taurine 0.5 MG/ML / threonine 3.6 MG/ML / tryptophan 1.25 MG/ML / tyrosine 0.44 MG/ML / valine 4.52 MG/ML Injectable Solution [Aminosyn-PF 7%]SBD2d212e10-7e08-4aeb-b63f-dcc9278977694
831426alanine 4.9 MG/ML / arginine 8.61 MG/ML / aspartate 3.7 MG/ML / glutamate 5.76 MG/ML / glycine 2.7 MG/ML / histidine 2.2 MG/ML / isoleucine 5.34 MG/ML / leucine 8.31 MG/ML / lysine 4.75 MG/ML / methionine 1.25 MG/ML / phenylalanine 3 MG/ML / proline 5.7 MG/ML / serine 3.47 MG/ML / taurine 0.5 MG/ML / threonine 3.6 MG/ML / tryptophan 1.25 MG/ML / tyrosine 0.44 MG/ML / valine 4.52 MG/ML Injectable SolutionSCD2d212e10-7e08-4aeb-b63f-dcc9278977694
831430Aminosyn-PF 7 % Injectable SolutionSY2d212e10-7e08-4aeb-b63f-dcc9278977694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-4178-030099041780312 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG12 bag2021-10-010000-00-00NoNoCurrent