Home NDC 0990-4179 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019492-002 AMINOSYN-PF 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019492-002 AMINOSYN-PF 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-10-17 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Aminosyn-PF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOLEUCINE 698 mg/100mL LEUCINE 1227 mg/100mL LYSINE ACETATE 527 mg/100mL METHIONINE 820 mg/100mL PHENYLALANINE 385 mg/100mL THREONINE 312 mg/100mL TRYPTOPHAN 760 mg/100mL VALINE 1200 mg/100mL ALANINE 677 mg/100mL ARGININE 180 mg/100mL ASPARTIC ACID 427 mg/100mL GLUTAMIC ACID 812 mg/100mL GLYCINE 495 mg/100mL HISTIDINE 70 mg/100mL PROLINE 512 mg/100mL SERINE 180 mg/100mL TAURINE 44 mg/100mL TYROSINE 673 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 18 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 800341 Internal RxNorm lookup 800345 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0990-4179-05 Aminosyn-PF 1000 mL in 1 BAG INJECTION, SOLUTION 1000 12 0990-4179-05 Aminosyn-PF 6 in 1 CASE INJECTION, SOLUTION 6 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0990-4179 AMINOSYN-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.] 11 Current NDC, Legacy NDC, 2 package rows 20241101_46e74ce4-cd7e-437f-bf54-ca9b98eb2663.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aminosyn-PF ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE ICU Medical Inc. 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 2025-10-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019492 application number: NDA019492 ndc (product): 0990-4179
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 800345 Aminosyn PF 10 % , Sulfite-Free Injectable Solution PSN 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 12 800345 alanine 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] SBD 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 12 800341 alanine 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 SCD 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 12 800345 Aminosyn PF 10 % , Sulfite-Free Injectable Solution SY 46e74ce4-cd7e-437f-bf54-ca9b98eb2663 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0990-4179-05 00990417905 6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG 6 bag 2019-11-01 0000-00-00 No No Current