clinimix e

Generic: leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clinimix e
Generic Name leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose
Labeler baxter healthcare company
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

alanine 1035 mg/100mL, arginine 575 mg/100mL, calcium chloride 33 mg/100mL, dextrose 20 g/100mL, glycine 515 mg/100mL, histidine 240 mg/100mL, isoleucine 300 mg/100mL, leucine 365 mg/100mL, lysine 290 mg/100mL, magnesium chloride 51 mg/100mL, methionine 200 mg/100mL, phenylalanine 280 mg/100mL, potassium phosphate, dibasic 261 mg/100mL, proline 340 mg/100mL, serine 250 mg/100mL, sodium acetate 340 mg/100mL, sodium chloride 59 mg/100mL, threonine 210 mg/100mL, tryptophan 90 mg/100mL, tyrosine 20 mg/100mL, valine 290 mg/100mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-7034
Product ID 0338-7034_dc7ce216-a4a9-41cf-80e3-5e901b8cecdf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020678
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

Pharmacologic Class

Established (EPC)
amino acid [epc]
Chemical Structure
amino acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03387034
Hyphenated Format 0338-7034

Supplemental Identifiers

RxCUI
800998 801000 801010 801012 801019 801021 801029 801031 1090635 1090639
UNII
HG18B9YRS7 04Y7590D77 02F3473H9O 47E5O17Y3R AE28F7PNPL CI71S98N1Z 8DUH1N11BX 2ZD004190S 452VLY9402 9DLQ4CIU6V OF5P57N2ZX 42HK56048U GMW67QNF9C M4I0D6VV5M K3Z4F929H6 IY9XDZ35W2 94ZLA3W45F 451W47IQ8X TE7660XO1C 4QD397987E 4550K0SC9B
NUI
N0000175780 M0000922

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clinimix e (source: ndc)
Generic Name leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose (source: ndc)
Application Number NDA020678 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1035 mg/100mL
  • 575 mg/100mL
  • 33 mg/100mL
  • 20 g/100mL
  • 515 mg/100mL
  • 240 mg/100mL
  • 300 mg/100mL
  • 365 mg/100mL
  • 290 mg/100mL
  • 51 mg/100mL
  • 200 mg/100mL
  • 280 mg/100mL
  • 261 mg/100mL
  • 340 mg/100mL
  • 250 mg/100mL
  • 59 mg/100mL
  • 210 mg/100mL
  • 90 mg/100mL
  • 20 mg/100mL
source: ndc
Packaging
  • 6 BAG in 1 CARTON (0338-7034-06) / 1000 mL in 1 BAG (0338-7034-01)
source: ndc

Packages (1)

0338-7034-06 6 BAG in 1 CARTON (0338-7034-06) / 1000 mL in 1 BAG (0338-7034-01)

Ingredients (21)

alanine (1035 mg/100mL) arginine (575 mg/100mL) calcium chloride (33 mg/100mL) dextrose (20 g/100mL) glycine (515 mg/100mL) histidine (240 mg/100mL) isoleucine (300 mg/100mL) leucine (365 mg/100mL) lysine (290 mg/100mL) magnesium chloride (51 mg/100mL) methionine (200 mg/100mL) phenylalanine (280 mg/100mL) potassium phosphate, dibasic (261 mg/100mL) proline (340 mg/100mL) serine (250 mg/100mL) sodium acetate (340 mg/100mL) sodium chloride (59 mg/100mL) threonine (210 mg/100mL) tryptophan (90 mg/100mL) tyrosine (20 mg/100mL) valine (290 mg/100mL)

Linked Drug Pages (1)

CLINIMIX E ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "dc7ce216-a4a9-41cf-80e3-5e901b8cecdf", "openfda": {"nui": ["N0000175780", "M0000922"], "unii": ["HG18B9YRS7", "04Y7590D77", "02F3473H9O", "47E5O17Y3R", "AE28F7PNPL", "CI71S98N1Z", "8DUH1N11BX", "2ZD004190S", "452VLY9402", "9DLQ4CIU6V", "OF5P57N2ZX", "42HK56048U", "GMW67QNF9C", "M4I0D6VV5M", "K3Z4F929H6", "IY9XDZ35W2", "94ZLA3W45F", "451W47IQ8X", "TE7660XO1C", "4QD397987E", "4550K0SC9B"], "rxcui": ["800998", "801000", "801010", "801012", "801019", "801021", "801029", "801031", "1090635", "1090639"], "spl_set_id": ["8469d6fb-d6ef-476f-8cc3-0905192de0a8"], "pharm_class_cs": ["Amino Acids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BAG in 1 CARTON (0338-7034-06)  / 1000 mL in 1 BAG (0338-7034-01)", "package_ndc": "0338-7034-06", "marketing_start_date": "20240715"}], "brand_name": "CLINIMIX E", "product_id": "0338-7034_dc7ce216-a4a9-41cf-80e3-5e901b8cecdf", "dosage_form": "INJECTION", "pharm_class": ["Amino Acid [EPC]", "Amino Acids [CS]", "Blood Coagulation Factor [EPC]", "Calcium [CS]", "Calculi Dissolution Agent [EPC]", "Cations", "Divalent [CS]", "Increased Coagulation Factor Activity [PE]", "Increased Large Intestinal Motility [PE]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "0338-7034", "generic_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLINIMIX E", "active_ingredients": [{"name": "ALANINE", "strength": "1035 mg/100mL"}, {"name": "ARGININE", "strength": "575 mg/100mL"}, {"name": "CALCIUM CHLORIDE", "strength": "33 mg/100mL"}, {"name": "DEXTROSE", "strength": "20 g/100mL"}, {"name": "GLYCINE", "strength": "515 mg/100mL"}, {"name": "HISTIDINE", "strength": "240 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "300 mg/100mL"}, {"name": "LEUCINE", "strength": "365 mg/100mL"}, {"name": "LYSINE", "strength": "290 mg/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "51 mg/100mL"}, {"name": "METHIONINE", "strength": "200 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "280 mg/100mL"}, {"name": "POTASSIUM PHOSPHATE, DIBASIC", "strength": "261 mg/100mL"}, {"name": "PROLINE", "strength": "340 mg/100mL"}, {"name": "SERINE", "strength": "250 mg/100mL"}, {"name": "SODIUM ACETATE", "strength": "340 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "59 mg/100mL"}, {"name": "THREONINE", "strength": "210 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "90 mg/100mL"}, {"name": "TYROSINE", "strength": "20 mg/100mL"}, {"name": "VALINE", "strength": "290 mg/100mL"}], "application_number": "NDA020678", "marketing_category": "NDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}