Aminosyn

Product NDC
0409-4191
11-digit product format
004094191
Labeler code
0409
Product ID
0409-4191_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
720 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-4191DDiscontinued by firm2026-10-05
excluded packagepackage0409-41910409-4191-03DDiscontinued by firm2026-10-05
excluded packagepackage0409-41910409-4191-05DDiscontinued by firm2026-10-05

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-4191-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-4191-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-4191-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-4191-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-4191-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-4191-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-4191-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-4191-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-4191-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-4191-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-4191-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-4191-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-4191-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-4191-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-4191-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-4191-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-4191-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-4191-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-4191-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-4191-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-4191-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-4191-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-4191-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-4191-03557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017673-001AMINOSYN 5%AMINO ACIDS5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-002AMINOSYN 7%AMINO ACIDS7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-003AMINOSYN 10%AMINO ACIDS10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-004AMINOSYN 8.5%AMINO ACIDS8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 1982
N017673-005AMINOSYN 8.5% W/ ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 1982
N017673-006AMINOSYN 7% (PH6)AMINO ACIDS7% (7GM/100ML)INJECTABLE / INJECTION1985-11-18
N017673-007AMINOSYN 8.5% (PH6)AMINO ACIDS8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-18
N017673-008AMINOSYN 10% (PH6)AMINO ACIDS10% (10GM/100ML)INJECTABLE / INJECTION1985-11-18
N017673-009AMINOSYN 8.5% W/ELECTROLYTESAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-1884e616aacf4f…
2026-09-14 22:38:342026-08N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-2584e616aacf4f…
2026-08-18 06:07:402026-07N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-005AMINOSYN 8.5% W/ ELECTROLYTES8.5%;102MG/100ML;522MG/100ML;410MG/100MLINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-006AMINOSYN 7% (PH6)7% (7GM/100ML)INJECTABLE / INJECTION1985-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-007AMINOSYN 8.5% (PH6)8.5% (8.5GM/100ML)INJECTABLE / INJECTION1985-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-008AMINOSYN 10% (PH6)10% (10GM/100ML)INJECTABLE / INJECTION1985-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017673-009AMINOSYN 8.5% W/ELECTROLYTES8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100MLINJECTABLE / INJECTION2002-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N017673-001AMINOSYN 5%5% (5GM/100ML)INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017673-002AMINOSYN 7%7% (7GM/100ML)INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017673-003AMINOSYN 10%10% (10GM/100ML)INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017673-004AMINOSYN 8.5%8.5% (8.5GM/100ML)INJECTABLE / INJECTIONApproved before 19826a471c1ec25d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4191-03ML - Milliliter0409-4191633050c2-270a-46ff-9cbe-40aaad21991212012-07-24
0409-4191-05ML - Milliliter0409-419157f639d5-9b38-46f2-acc9-f0ba7ff55e8112012-07-24