FDA.reportPublic FDA data

Aminosyn-PF

Product NDC
0990-4179
11-digit product format
009904179
Labeler code
0990
Product ID
0990-4179_2d8f2280-bc20-45ba-bdf3-12c055684017
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
NDA019492
Marketing category
NDA
Marketing start
2019-11-01
Substance
ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
Active strength
698; 1227; 527; 820; 385; 312; 760; 1200; 677; 180; 427; 812; 495; 70; 512; 180; 44; 673 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
ALANINE698 mg/100mL
ARGININE1227 mg/100mL
ASPARTIC ACID527 mg/100mL
GLUTAMIC ACID820 mg/100mL
GLYCINE385 mg/100mL
HISTIDINE312 mg/100mL
ISOLEUCINE760 mg/100mL
LEUCINE1200 mg/100mL
LYSINE ACETATE677 mg/100mL
METHIONINE180 mg/100mL
PHENYLALANINE427 mg/100mL
PROLINE812 mg/100mL
SERINE495 mg/100mL
TAURINE70 mg/100mL
THREONINE512 mg/100mL
TRYPTOPHAN180 mg/100mL
TYROSINE44 mg/100mL
VALINE673 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
Rxcui800341, 800345

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
0990-4179-05Aminosyn-PF1000 mL in 1 BAGINJECTION, SOLUTION100012
0990-4179-05Aminosyn-PF6 in 1 CASEINJECTION, SOLUTION612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-4179-05ML - Milliliter0990-4179f6186eff-f827-42ea-9895-858a8e6399ee12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-4179AMINOSYN-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.]11Current NDC, Legacy NDC, 2 package rows20241101_46e74ce4-cd7e-437f-bf54-ca9b98eb2663.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
800345Aminosyn PF 10 % , Sulfite-Free Injectable SolutionPSN46e74ce4-cd7e-437f-bf54-ca9b98eb266312
800345alanine 6.98 MG/ML / arginine 12.3 MG/ML / aspartate 5.27 MG/ML / glutamate 8.2 MG/ML / glycine 3.85 MG/ML / histidine 3.12 MG/ML / isoleucine 7.6 MG/ML / leucine 12 MG/ML / lysine 6.77 MG/ML / methionine 1.8 MG/ML / phenylalanine 4.27 MG/ML / proline 8.12 MG/ML / serine 4.95 MG/ML / taurine 0.7 MG/ML / threonine 5.12 MG/ML / tryptophan 1.8 MG/ML / tyrosine 0.44 MG/ML / valine 6.73 MG/ML Injectable Solution [Aminosyn-PF 10 %, Sulfite-Free]SBD46e74ce4-cd7e-437f-bf54-ca9b98eb266312
800341alanine 6.98 MG/ML / arginine 12.3 MG/ML / aspartate 5.27 MG/ML / glutamate 8.2 MG/ML / glycine 3.85 MG/ML / histidine 3.12 MG/ML / isoleucine 7.6 MG/ML / leucine 12 MG/ML / lysine 6.77 MG/ML / methionine 1.8 MG/ML / phenylalanine 4.27 MG/ML / proline 8.12 MG/ML / serine 4.95 MG/ML / taurine 0.7 MG/ML / threonine 5.12 MG/ML / tryptophan 1.8 MG/ML / tyrosine 0.44 MG/ML / valine 6.73 MG/ML Injectable SolutionSCD46e74ce4-cd7e-437f-bf54-ca9b98eb266312
800345Aminosyn PF 10 % , Sulfite-Free Injectable SolutionSY46e74ce4-cd7e-437f-bf54-ca9b98eb266312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-4179-05009904179056 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG6 bag2019-11-010000-00-00NoNoCurrent