Home NDC 0409-4187 Aminosyn
Product NDC 0409-4187
11-digit product format 004094187
Labeler code 0409
Product ID 0409-4187_dad76e26-0274-4501-abaf-216a4165a2ae
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 NDA017673
Marketing category NDA
Marketing start 2012-03-06
Marketing end 0000-00-00
Substance ISOLEUCINE; LEU
Active strength 620 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-4187-03 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-4187-03 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-4187-03 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-4187-03 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-4187-03 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-4187-03 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-4187-03 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-4187-03 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-4187-03 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0409-4187-03 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0409-4187-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0409-4187-03 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 9 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017673-001 AMINOSYN 5% AMINO ACIDS 5% (5GM/100ML) INJECTABLE / INJECTION Approved before 1982 N017673-002 AMINOSYN 7% AMINO ACIDS 7% (7GM/100ML) INJECTABLE / INJECTION Approved before 1982 N017673-003 AMINOSYN 10% AMINO ACIDS 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 N017673-004 AMINOSYN 8.5% AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 N017673-005 AMINOSYN 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 8.5%;102MG/100ML;522MG/100ML;410MG/100ML INJECTABLE / INJECTION Approved before 1982 N017673-006 AMINOSYN 7% (PH6) AMINO ACIDS 7% (7GM/100ML) INJECTABLE / INJECTION 1985-11-18 N017673-007 AMINOSYN 8.5% (PH6) AMINO ACIDS 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1985-11-18 N017673-008 AMINOSYN 10% (PH6) AMINO ACIDS 10% (10GM/100ML) INJECTABLE / INJECTION 1985-11-18 N017673-009 AMINOSYN 8.5% W/ELECTROLYTES AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML INJECTABLE / INJECTION 2002-10-25
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 10 · 387 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 2026-09-14 22:38:34 2026-08 N017673-001 AMINOSYN 5% 5% (5GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-002 AMINOSYN 7% 7% (7GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-003 AMINOSYN 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-004 AMINOSYN 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-005 AMINOSYN 8.5% W/ ELECTROLYTES 8.5%;102MG/100ML;522MG/100ML;410MG/100ML INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-006 AMINOSYN 7% (PH6) 7% (7GM/100ML) INJECTABLE / INJECTION 1985-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-007 AMINOSYN 8.5% (PH6) 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1985-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-008 AMINOSYN 10% (PH6) 10% (10GM/100ML) INJECTABLE / INJECTION 1985-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017673-009 AMINOSYN 8.5% W/ELECTROLYTES 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML INJECTABLE / INJECTION 2002-10-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N017673-001 AMINOSYN 5% 5% (5GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-002 AMINOSYN 7% 7% (7GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-003 AMINOSYN 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-004 AMINOSYN 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-005 AMINOSYN 8.5% W/ ELECTROLYTES 8.5%;102MG/100ML;522MG/100ML;410MG/100ML INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-006 AMINOSYN 7% (PH6) 7% (7GM/100ML) INJECTABLE / INJECTION 1985-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-007 AMINOSYN 8.5% (PH6) 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1985-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-008 AMINOSYN 10% (PH6) 10% (10GM/100ML) INJECTABLE / INJECTION 1985-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017673-009 AMINOSYN 8.5% W/ELECTROLYTES 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML INJECTABLE / INJECTION 2002-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017673-001 AMINOSYN 5% 5% (5GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-002 AMINOSYN 7% 7% (7GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-003 AMINOSYN 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-004 AMINOSYN 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-005 AMINOSYN 8.5% W/ ELECTROLYTES 8.5%;102MG/100ML;522MG/100ML;410MG/100ML INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-006 AMINOSYN 7% (PH6) 7% (7GM/100ML) INJECTABLE / INJECTION 1985-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-007 AMINOSYN 8.5% (PH6) 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1985-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-008 AMINOSYN 10% (PH6) 10% (10GM/100ML) INJECTABLE / INJECTION 1985-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017673-009 AMINOSYN 8.5% W/ELECTROLYTES 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML INJECTABLE / INJECTION 2002-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-001 AMINOSYN 5% 5% (5GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-002 AMINOSYN 7% 7% (7GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-003 AMINOSYN 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-004 AMINOSYN 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-005 AMINOSYN 8.5% W/ ELECTROLYTES 8.5%;102MG/100ML;522MG/100ML;410MG/100ML INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-006 AMINOSYN 7% (PH6) 7% (7GM/100ML) INJECTABLE / INJECTION 1985-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-007 AMINOSYN 8.5% (PH6) 8.5% (8.5GM/100ML) INJECTABLE / INJECTION 1985-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-008 AMINOSYN 10% (PH6) 10% (10GM/100ML) INJECTABLE / INJECTION 1985-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017673-009 AMINOSYN 8.5% W/ELECTROLYTES 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML INJECTABLE / INJECTION 2002-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017673-001 AMINOSYN 5% 5% (5GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017673-002 AMINOSYN 7% 7% (7GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017673-003 AMINOSYN 10% 10% (10GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017673-004 AMINOSYN 8.5% 8.5% (8.5GM/100ML) INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.