Home NDC 0990-4178 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 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 N019398-001 AMINOSYN-PF 7% AMINO ACIDS 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06
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 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019398-001 AMINOSYN-PF 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1985-09-06 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 490 mg/100mL LEUCINE 861 mg/100mL LYSINE ACETATE 370 mg/100mL METHIONINE 576 mg/100mL PHENYLALANINE 270 mg/100mL THREONINE 220 mg/100mL TRYPTOPHAN 534 mg/100mL VALINE 831 mg/100mL ALANINE 475 mg/100mL ARGININE 125 mg/100mL ASPARTIC ACID 300 mg/100mL GLUTAMIC ACID 570 mg/100mL GLYCINE 347 mg/100mL HISTIDINE 50 mg/100mL PROLINE 360 mg/100mL SERINE 125 mg/100mL TAURINE 44 mg/100mL TYROSINE 452 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 831426 Internal RxNorm lookup 831430 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 0990-4178-03 Aminosyn-PF 500 mL in 1 BAG INJECTION, SOLUTION 500 4 0990-4178-03 Aminosyn-PF 12 in 1 CASE INJECTION, SOLUTION 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0990-4178 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.] 3 Current NDC, Legacy NDC, 2 package rows 20231129_2d212e10-7e08-4aeb-b63f-dcc927897769.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. 2d212e10-7e08-4aeb-b63f-dcc927897769 2025-10-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 019398 application number: NDA019398 ndc (product): 0990-4178
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 831430 Aminosyn-PF 7 % Injectable Solution PSN 2d212e10-7e08-4aeb-b63f-dcc927897769 4 831430 alanine 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%] SBD 2d212e10-7e08-4aeb-b63f-dcc927897769 4 831426 alanine 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 SCD 2d212e10-7e08-4aeb-b63f-dcc927897769 4 831430 Aminosyn-PF 7 % Injectable Solution SY 2d212e10-7e08-4aeb-b63f-dcc927897769 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0990-4178-03 00990417803 12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG 12 bag 2021-10-01 0000-00-00 No No Current