NDC Code(s) : 0409-4187-03, 0409-4191-05, 0409-4191-03, 0409-4184-03, 0409-4159-05, 0409-4181-05, 0409-4181-03
Packager : Hospira, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4187
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE(UNII: 04Y7590D77)
(ISOLEUCINE - UNII:04Y7590D77) 		ISOLEUCINE620 mg in 100 mL
LEUCINE(UNII: GMW67QNF9C)
(LEUCINE - UNII:GMW67QNF9C) 		LEUCINE810 mg in 100 mL
LYSINE ACETATE(UNII: TTL6G7LIWZ)
(LYSINE - UNII:K3Z4F929H6) 		LYSINE624 mg in 100 mL
METHIONINE(UNII: AE28F7PNPL)
(METHIONINE - UNII:AE28F7PNPL) 		METHIONINE340 mg in 100 mL
PHENYLALANINE(UNII: 47E5O17Y3R)
(PHENYLALANINE - UNII:47E5O17Y3R) 		PHENYLALANINE380 mg in 100 mL
THREONINE(UNII: 2ZD004190S)
(THREONINE - UNII:2ZD004190S) 		THREONINE460 mg in 100 mL
TRYPTOPHAN(UNII: 8DUH1N11BX)
(TRYPTOPHAN - UNII:8DUH1N11BX) 		TRYPTOPHAN150 mg in 100 mL
VALINE(UNII: HG18B9YRS7)
(VALINE - UNII:HG18B9YRS7) 		VALINE680 mg in 100 mL
ALANINE(UNII: OF5P57N2ZX)
(ALANINE - UNII:OF5P57N2ZX) 		ALANINE1100 mg in 100 mL
ARGININE(UNII: 94ZLA3W45F)
(ARGININE - UNII:94ZLA3W45F) 		ARGININE850 mg in 100 mL
HISTIDINE(UNII: 4QD397987E)
(HISTIDINE - UNII:4QD397987E) 		HISTIDINE260 mg in 100 mL
PROLINE(UNII: 9DLQ4CIU6V)
(PROLINE - UNII:9DLQ4CIU6V) 		PROLINE750 mg in 100 mL
SERINE(UNII: 452VLY9402)
(SERINE - UNII:452VLY9402) 		SERINE370 mg in 100 mL
TYROSINE(UNII: 42HK56048U)
(TYROSINE - UNII:42HK56048U) 		TYROSINE44 mg in 100 mL
GLYCINE(UNII: TE7660XO1C)
(GLYCINE - UNII:TE7660XO1C) 		GLYCINE1100 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-4187-0312 in 1 CASE
11 in 1 POUCH
1500 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017673 03/06/2012
AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4191
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE(UNII: 04Y7590D77)
(ISOLEUCINE - UNII:04Y7590D77) 		ISOLEUCINE720 mg in 100 mL
LEUCINE(UNII: GMW67QNF9C)
(LEUCINE - UNII:GMW67QNF9C) 		LEUCINE940 mg in 100 mL
LYSINE ACETATE(UNII: TTL6G7LIWZ)
(LYSINE - UNII:K3Z4F929H6) 		LYSINE720 mg in 100 mL
METHIONINE(UNII: AE28F7PNPL)
(METHIONINE - UNII:AE28F7PNPL) 		METHIONINE400 mg in 100 mL
PHENYLALANINE(UNII: 47E5O17Y3R)
(PHENYLALANINE - UNII:47E5O17Y3R) 		PHENYLALANINE440 mg in 100 mL
THREONINE(UNII: 2ZD004190S)
(THREONINE - UNII:2ZD004190S) 		THREONINE520 mg in 100 mL
TRYPTOPHAN(UNII: 8DUH1N11BX)
(TRYPTOPHAN - UNII:8DUH1N11BX) 		TRYPTOPHAN160 mg in 100 mL
VALINE(UNII: HG18B9YRS7)
(VALINE - UNII:HG18B9YRS7) 		VALINE800 mg in 100 mL
ALANINE(UNII: OF5P57N2ZX)
(ALANINE - UNII:OF5P57N2ZX) 		ALANINE1280 mg in 100 mL
ARGININE(UNII: 94ZLA3W45F)
(ARGININE - UNII:94ZLA3W45F) 		ARGININE980 mg in 100 mL
HISTIDINE(UNII: 4QD397987E)
(HISTIDINE - UNII:4QD397987E) 		HISTIDINE300 mg in 100 mL
PROLINE(UNII: 9DLQ4CIU6V)
(PROLINE - UNII:9DLQ4CIU6V) 		PROLINE860 mg in 100 mL
SERINE(UNII: 452VLY9402)
(SERINE - UNII:452VLY9402) 		SERINE420 mg in 100 mL
TYROSINE(UNII: 42HK56048U)
(TYROSINE - UNII:42HK56048U) 		TYROSINE44 mg in 100 mL
GLYCINE(UNII: TE7660XO1C)
(GLYCINE - UNII:TE7660XO1C) 		GLYCINE1280 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-4191-056 in 1 CASE
11 in 1 POUCH
11000 mL in 1 BAG
2NDC:0409-4191-0312 in 1 CASE
21 in 1 POUCH
2500 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017673 03/06/2012
AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4184
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE(UNII: 04Y7590D77)
(ISOLEUCINE - UNII:04Y7590D77) 		ISOLEUCINE510 mg in 100 mL
LEUCINE(UNII: GMW67QNF9C)
(LEUCINE - UNII:GMW67QNF9C) 		LEUCINE660 mg in 100 mL
LYSINE ACETATE(UNII: TTL6G7LIWZ)
(LYSINE - UNII:K3Z4F929H6) 		LYSINE510 mg in 100 mL
METHIONINE(UNII: AE28F7PNPL)
(METHIONINE - UNII:AE28F7PNPL) 		METHIONINE280 mg in 100 mL
PHENYLALANINE(UNII: 47E5O17Y3R)
(PHENYLALANINE - UNII:47E5O17Y3R) 		PHENYLALANINE310 mg in 100 mL
THREONINE(UNII: 2ZD004190S)
(THREONINE - UNII:2ZD004190S) 		THREONINE370 mg in 100 mL
TRYPTOPHAN(UNII: 8DUH1N11BX)
(TRYPTOPHAN - UNII:8DUH1N11BX) 		TRYPTOPHAN120 mg in 100 mL
VALINE(UNII: HG18B9YRS7)
(VALINE - UNII:HG18B9YRS7) 		VALINE560 mg in 100 mL
ALANINE(UNII: OF5P57N2ZX)
(ALANINE - UNII:OF5P57N2ZX) 		ALANINE900 mg in 100 mL
ARGININE(UNII: 94ZLA3W45F)
(ARGININE - UNII:94ZLA3W45F) 		ARGININE690 mg in 100 mL
HISTIDINE(UNII: 4QD397987E)
(HISTIDINE - UNII:4QD397987E) 		HISTIDINE210 mg in 100 mL
PROLINE(UNII: 9DLQ4CIU6V)
(PROLINE - UNII:9DLQ4CIU6V) 		PROLINE610 mg in 100 mL
SERINE(UNII: 452VLY9402)
(SERINE - UNII:452VLY9402) 		SERINE300 mg in 100 mL
TYROSINE(UNII: 42HK56048U)
(TYROSINE - UNII:42HK56048U) 		TYROSINE44 mg in 100 mL
GLYCINE(UNII: TE7660XO1C)
(GLYCINE - UNII:TE7660XO1C) 		GLYCINE900 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-4184-0312 in 1 CASE
11 in 1 POUCH
1500 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017673 10/01/2010 11/01/2010
AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4159
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE(UNII: 04Y7590D77)
(ISOLEUCINE - UNII:04Y7590D77) 		ISOLEUCINE252 mg in 100 mL
LEUCINE(UNII: GMW67QNF9C)
(LEUCINE - UNII:GMW67QNF9C) 		LEUCINE329 mg in 100 mL
LYSINE ACETATE(UNII: TTL6G7LIWZ)
(LYSINE - UNII:K3Z4F929H6) 		LYSINE252 mg in 100 mL
METHIONINE(UNII: AE28F7PNPL)
(METHIONINE - UNII:AE28F7PNPL) 		METHIONINE140 mg in 100 mL
PHENYLALANINE(UNII: 47E5O17Y3R)
(PHENYLALANINE - UNII:47E5O17Y3R) 		PHENYLALANINE154 mg in 100 mL
THREONINE(UNII: 2ZD004190S)
(THREONINE - UNII:2ZD004190S) 		THREONINE182 mg in 100 mL
TRYPTOPHAN(UNII: 8DUH1N11BX)
(TRYPTOPHAN - UNII:8DUH1N11BX) 		TRYPTOPHAN56 mg in 100 mL
VALINE(UNII: HG18B9YRS7)
(VALINE - UNII:HG18B9YRS7) 		VALINE280 mg in 100 mL
ALANINE(UNII: OF5P57N2ZX)
(ALANINE - UNII:OF5P57N2ZX) 		ALANINE448 mg in 100 mL
ARGININE(UNII: 94ZLA3W45F)
(ARGININE - UNII:94ZLA3W45F) 		ARGININE343 mg in 100 mL
HISTIDINE(UNII: 4QD397987E)
(HISTIDINE - UNII:4QD397987E) 		HISTIDINE105 mg in 100 mL
PROLINE(UNII: 9DLQ4CIU6V)
(PROLINE - UNII:9DLQ4CIU6V) 		PROLINE300 mg in 100 mL
SERINE(UNII: 452VLY9402)
(SERINE - UNII:452VLY9402) 		SERINE147 mg in 100 mL
TYROSINE(UNII: 42HK56048U)
(TYROSINE - UNII:42HK56048U) 		TYROSINE31 mg in 100 mL
GLYCINE(UNII: TE7660XO1C)
(GLYCINE - UNII:TE7660XO1C) 		GLYCINE448 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-4159-056 in 1 CASE
11 in 1 POUCH
11000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017789 12/01/2010 01/01/2011
AminosynISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4181
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE(UNII: 04Y7590D77)
(ISOLEUCINE - UNII:04Y7590D77) 		ISOLEUCINE360 mg in 100 mL
LEUCINE(UNII: GMW67QNF9C)
(LEUCINE - UNII:GMW67QNF9C) 		LEUCINE470 mg in 100 mL
LYSINE ACETATE(UNII: TTL6G7LIWZ)
(LYSINE - UNII:K3Z4F929H6) 		LYSINE360 mg in 100 mL
METHIONINE(UNII: AE28F7PNPL)
(METHIONINE - UNII:AE28F7PNPL) 		METHIONINE200 mg in 100 mL
PHENYLALANINE(UNII: 47E5O17Y3R)
(PHENYLALANINE - UNII:47E5O17Y3R) 		PHENYLALANINE220 mg in 100 mL
THREONINE(UNII: 2ZD004190S)
(THREONINE - UNII:2ZD004190S) 		THREONINE260 mg in 100 mL
TRYPTOPHAN(UNII: 8DUH1N11BX)
(TRYPTOPHAN - UNII:8DUH1N11BX) 		TRYPTOPHAN80 mg in 100 mL
VALINE(UNII: HG18B9YRS7)
(VALINE - UNII:HG18B9YRS7) 		VALINE400 mg in 100 mL
ALANINE(UNII: OF5P57N2ZX)
(ALANINE - UNII:OF5P57N2ZX) 		ALANINE640 mg in 100 mL
ARGININE(UNII: 94ZLA3W45F)
(ARGININE - UNII:94ZLA3W45F) 		ARGININE490 mg in 100 mL
HISTIDINE(UNII: 4QD397987E)
(HISTIDINE - UNII:4QD397987E) 		HISTIDINE150 mg in 100 mL
PROLINE(UNII: 9DLQ4CIU6V)
(PROLINE - UNII:9DLQ4CIU6V) 		PROLINE430 mg in 100 mL
SERINE(UNII: 452VLY9402)
(SERINE - UNII:452VLY9402) 		SERINE210 mg in 100 mL
TYROSINE(UNII: 42HK56048U)
(TYROSINE - UNII:42HK56048U) 		TYROSINE44 mg in 100 mL
GLYCINE(UNII: TE7660XO1C)
(GLYCINE - UNII:TE7660XO1C) 		GLYCINE640 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID(UNII: Q40Q9N063P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0409-4181-056 in 1 CASE
11 in 1 POUCH
11000 mL in 1 BAG
2NDC:0409-4181-0312 in 1 CASE
21 in 1 POUCH
2500 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017673 05/01/2010 06/01/2010

PRINCIPAL DISPLAY PANEL

Label NDC 0409-4159-05

PRINCIPAL DISPLAY PANEL

Label NDC 0409-4181-03

PRINCIPAL DISPLAY PANEL

Label NDC 0409-4184-03

PRINCIPAL DISPLAY PANEL

Label NDC 0409-4187-03

PRINCIPAL DISPLAY PANEL

Label NDC 0409-4191-03