Aminosyn II

Product NDC: 0409-7121
11-digit product format: 004097121
Labeler code: 0409
Product ID: 0409-7121_d35d54e3-7e26-4c98-8fee-f88ce2eac095
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: NDA020015
Marketing category: NDA
Marketing start: 1991-12-19
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: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0409-7121		D	Discontinued by firm		2026-07-31
excluded package	package	0409-7121	0409-7121-07	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020015-001	AMINOSYN II 10% IN PLASTIC CONTAINER	AMINO ACIDS	10% (10GM/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.

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
2026-08-01 22:54:32	2026-06	N020015-001	AMINOSYN II 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION			1991-12-19	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 020015 application number: NDA020015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-7121-07	ML - Milliliter	0409-7121	7dbcbe0e-e5cb-4583-95b5-42e95b6b1ba8	1	2012-07-24