Home NDC 0409-4164 Aminosyn II
Product NDC 0409-4164
11-digit product format 004094164
Labeler code 0409
Product ID 0409-4164_035eb1a0-d767-4dbf-8f4a-6ea72f9a3cb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA019438
Marketing category NDA
Marketing start 2005-09-01
Marketing end 0000-00-00
Substance ISOLEUCINE; LEU
Active strength 660 mg/100mL; mg/10
Pharmacologic classes Amino Acid [EPC
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019438-001 AMINOSYN II 3.5% AMINO ACIDS 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 N019438-002 AMINOSYN II 5% AMINO ACIDS 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 N019438-003 AMINOSYN II 7% AMINO ACIDS 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 N019438-004 AMINOSYN II 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 N019438-005 AMINOSYN II 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03
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 6 · 210 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 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019438-001 AMINOSYN II 3.5% 3.5% (3.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019438-002 AMINOSYN II 5% 5% (5GM/100ML) INJECTABLE / INJECTION 1986-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019438-003 AMINOSYN II 7% 7% (7GM/100ML) INJECTABLE / INJECTION 1986-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019438-004 AMINOSYN II 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1986-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019438-005 AMINOSYN II 10% 10% (10GM/100ML) INJECTABLE / INJECTION 1986-04-03 2680178bc6a6…