Aminosyn II (Page 4 of 4)

HOW SUPPLIED

Aminosyn II is supplied as a Pharmacy Bulk Package in a 2000 mL flexible container for continuous admixture compounding procedures. Two concentrations are available:

Aminosyn II 10%, Sulfite-Free NDC 0409-7172-17

Aminosyn II 15%, Sulfite-Free

NDC 0409-7171-17

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light.

Revised: November, 2010

Printed in USA EN-2701

Hospira, Inc., Lake Forest, IL 60045 USA

IM-2038

IV Bag ndc 0409-7171-17
(click image for full-size original)

IM-2118

iv bag ndc 0409-7172-17
(click image for full-size original)
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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7172
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 660 mg in 100 mL
LEUCINE (LEUCINE) LEUCINE 1000 mg in 100 mL
LYSINE ACETATE (LYSINE) LYSINE 1050 mg in 100 mL
METHIONINE (METHIONINE) METHIONINE 172 mg in 100 mL
PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 298 mg in 100 mL
THREONINE (THREONINE) THREONINE 400 mg in 100 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 200 mg in 100 mL
VALINE (VALINE) VALINE 500 mg in 100 mL
ALANINE (ALANINE) ALANINE 993 mg in 100 mL
ARGININE (ARGININE) ARGININE 1018 mg in 100 mL
ASPARTIC ACID (ASPARTIC ACID) ASPARTIC ACID 700 mg in 100 mL
GLUTAMIC ACID (GLUTAMIC ACID) GLUTAMIC ACID 738 mg in 100 mL
HISTIDINE (HISTIDINE) HISTIDINE 300 mg in 100 mL
PROLINE (PROLINE) PROLINE 722 mg in 100 mL
SERINE (SERINE) SERINE 530 mg in 100 mL
N-ACETYLTYROSINE (N-ACETYLTYROSINE) N-ACETYLTYROSINE 270 mg in 100 mL
GLYCINE (GLYCINE) GLYCINE 500 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-7172-17 6 POUCH in 1 CASE contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CASE (0409-7172-17) and contains a BAG
1 2000 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-7172-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020015 12/19/1991 12/01/2020
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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7171
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 990 mg in 100 mL
LEUCINE (LEUCINE) LEUCINE 1500 mg in 100 mL
LYSINE ACETATE (LYSINE) LYSINE 1575 mg in 100 mL
METHIONINE (METHIONINE) METHIONINE 258 mg in 100 mL
PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 447 mg in 100 mL
THREONINE (THREONINE) THREONINE 600 mg in 100 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 300 mg in 100 mL
VALINE (VALINE) VALINE 750 mg in 100 mL
ALANINE (ALANINE) ALANINE 1490 mg in 100 mL
ARGININE (ARGININE) ARGININE 1527 mg in 100 mL
ASPARTIC ACID (ASPARTIC ACID) ASPARTIC ACID 1050 mg in 100 mL
GLUTAMIC ACID (GLUTAMIC ACID) GLUTAMIC ACID 1107 mg in 100 mL
HISTIDINE (HISTIDINE) HISTIDINE 450 mg in 100 mL
PROLINE (PROLINE) PROLINE 1083 mg in 100 mL
SERINE (SERINE) SERINE 795 mg in 100 mL
N-ACETYLTYROSINE (N-ACETYLTYROSINE) N-ACETYLTYROSINE 405 mg in 100 mL
GLYCINE (GLYCINE) GLYCINE 750 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-7171-17 6 POUCH in 1 CASE contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CASE (0409-7171-17) and contains a BAG
1 2000 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-7171-17)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020041 12/19/1991 12/01/2023
Labeler — Hospira, Inc. (141588017)

Revised: 09/2020 Hospira, Inc.

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