Home NDC 0990-7171 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 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 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER AMINO ACIDS 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19
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 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020041-001 AMINOSYN II 15% IN PLASTIC CONTAINER 15% (15GM/100ML) INJECTABLE / INJECTION 1991-12-19 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Aminosyn II
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOLEUCINE 405 mg/100mL LEUCINE 1490 mg/100mL LYSINE ACETATE 1527 mg/100mL METHIONINE 1050 mg/100mL PHENYLALANINE 1107 mg/100mL THREONINE 750 mg/100mL TRYPTOPHAN 450 mg/100mL VALINE 990 mg/100mL ALANINE 1500 mg/100mL ARGININE 1575 mg/100mL ASPARTIC ACID 258 mg/100mL GLUTAMIC ACID 447 mg/100mL HISTIDINE 1083 mg/100mL PROLINE 795 mg/100mL SERINE 600 mg/100mL ACETYL L-TYROSINE 300 mg/100mL GLYCINE 750 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 17 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 800188 Internal RxNorm lookup 800192 Internal RxNorm lookup 800237 Internal RxNorm lookup 800241 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 0990-7171-17 Aminosyn II 6 in 1 CASE INJECTION, SOLUTION 6 13 0990-7171-17 Aminosyn II 1 in 1 POUCH INJECTION, SOLUTION 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0990-7171 AMINOSYN 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.] 8 Current NDC, Legacy NDC, 2 package rows 20231129_5b426208-f090-4650-86c3-89040ba45c2d.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 II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE ICU Medical Inc. 5b426208-f090-4650-86c3-89040ba45c2d 2025-11-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020041 application number: NDA020041 ndc (product): 0990-7171
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 800241 Aminosyn II 10 % Injectable Solution PSN 5b426208-f090-4650-86c3-89040ba45c2d 13 800192 Aminosyn II 15 % Injectable Solution PSN 5b426208-f090-4650-86c3-89040ba45c2d 13 800192 alanine 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%] SBD 5b426208-f090-4650-86c3-89040ba45c2d 13 800241 alanine 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 %] SBD 5b426208-f090-4650-86c3-89040ba45c2d 13 800188 alanine 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 SCD 5b426208-f090-4650-86c3-89040ba45c2d 13 800237 alanine 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 SCD 5b426208-f090-4650-86c3-89040ba45c2d 13 800241 Aminosyn II 10 % Injectable Solution SY 5b426208-f090-4650-86c3-89040ba45c2d 13 800192 Aminosyn II 15 % Injectable Solution SY 5b426208-f090-4650-86c3-89040ba45c2d 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0990-7171-17 00990717117 6 POUCH in 1 CASE (0990-7171-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG 6 pouch 2019-11-01 0000-00-00 No No Current