ZX) ALANINE 1035 mg in 100 mL
GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE 515 mg in 100 mL
ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE 575 mg in 100 mL
PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE 340 mg in 100 mL
SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE 250 mg in 100 mL
TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE 20 mg in 100 mL
DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2) DEXTROSE 25 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID (UNII: Q40Q9N063P)
WATER (UNII: 059QF0KO0R)
NITROGEN (UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-1139-03 1000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020734 03/20/2012
CLINIMIX
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-1103
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE 365 mg in 100 mL
LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6) LYSINE 290 mg in 100 mL
METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL) METHIONINE 200 mg in 100 mL
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77) ISOLEUCINE 300 mg in 100 mL
VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE 290 mg in 100 mL
HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E) HISTIDINE 240 mg in 100 mL
THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S) THREONINE 210 mg in 100 mL
TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX) TRYPTOPHAN 90 mg in 100 mL
ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX) ALANINE 1035 mg in 100 mL
GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE 515 mg in 100 mL
ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE 575 mg in 100 mL
PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V) PROLINE 340 mg in 100 mL
SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402) SERINE 250 mg in 100 mL
TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U) TYROSINE 20 mg in 100 mL
DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2) DEXTROSE 25 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID (UNII: Q40Q9N063P)
WATER (UNII: 059QF0KO0R)
NITROGEN (UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-1103-04 2000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020734 03/20/201 |
