clinimix e

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

alanine 1656 mg/100mL, arginine 920 mg/100mL, calcium chloride 33 mg/100mL, dextrose 10 g/100mL, glycine 824 mg/100mL, histidine 384 mg/100mL, isoleucine 480 mg/100mL, leucine 584 mg/100mL, lysine 464 mg/100mL, magnesium chloride 51 mg/100mL, methionine 320 mg/100mL, phenylalanine 448 mg/100mL, potassium phosphate, dibasic 261 mg/100mL, proline 544 mg/100mL, serine 400 mg/100mL, sodium chloride 205 mg/100mL, threonine 336 mg/100mL, tryptophan 144 mg/100mL, tyrosine 32 mg/100mL, valine 464 mg/100mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 0338-0214
Product ID 0338-0214_dc7ce216-a4a9-41cf-80e3-5e901b8cecdf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020678
Listing Expiration 2026-12-31
Marketing Start 2020-09-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380214
Hyphenated Format 0338-0214

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, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose (source: ndc)
Application Number NDA020678 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1656 mg/100mL
  • 920 mg/100mL
  • 33 mg/100mL
  • 10 g/100mL
  • 824 mg/100mL
  • 384 mg/100mL
  • 480 mg/100mL
  • 584 mg/100mL
  • 464 mg/100mL
  • 51 mg/100mL
  • 320 mg/100mL
  • 448 mg/100mL
  • 261 mg/100mL
  • 544 mg/100mL
  • 400 mg/100mL
  • 205 mg/100mL
  • 336 mg/100mL
  • 144 mg/100mL
  • 32 mg/100mL
source: ndc
Packaging
  • 4 BAG in 1 CARTON (0338-0214-04) / 2000 mL in 1 BAG (0338-0214-01)
source: ndc

Packages (1)

0338-0214-04 4 BAG in 1 CARTON (0338-0214-04) / 2000 mL in 1 BAG (0338-0214-01)

Ingredients (20)

alanine (1656 mg/100mL) arginine (920 mg/100mL) calcium chloride (33 mg/100mL) dextrose (10 g/100mL) glycine (824 mg/100mL) histidine (384 mg/100mL) isoleucine (480 mg/100mL) leucine (584 mg/100mL) lysine (464 mg/100mL) magnesium chloride (51 mg/100mL) methionine (320 mg/100mL) phenylalanine (448 mg/100mL) potassium phosphate, dibasic (261 mg/100mL) proline (544 mg/100mL) serine (400 mg/100mL) sodium chloride (205 mg/100mL) threonine (336 mg/100mL) tryptophan (144 mg/100mL) tyrosine (32 mg/100mL) valine (464 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": "4 BAG in 1 CARTON (0338-0214-04)  / 2000 mL in 1 BAG (0338-0214-01)", "package_ndc": "0338-0214-04", "marketing_start_date": "20200921"}], "brand_name": "CLINIMIX E", "product_id": "0338-0214_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": "0338-0214", "generic_name": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, 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": "1656 mg/100mL"}, {"name": "ARGININE", "strength": "920 mg/100mL"}, {"name": "CALCIUM CHLORIDE", "strength": "33 mg/100mL"}, {"name": "DEXTROSE", "strength": "10 g/100mL"}, {"name": "GLYCINE", "strength": "824 mg/100mL"}, {"name": "HISTIDINE", "strength": "384 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "480 mg/100mL"}, {"name": "LEUCINE", "strength": "584 mg/100mL"}, {"name": "LYSINE", "strength": "464 mg/100mL"}, {"name": "MAGNESIUM CHLORIDE", "strength": "51 mg/100mL"}, {"name": "METHIONINE", "strength": "320 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "448 mg/100mL"}, {"name": "POTASSIUM PHOSPHATE, DIBASIC", "strength": "261 mg/100mL"}, {"name": "PROLINE", "strength": "544 mg/100mL"}, {"name": "SERINE", "strength": "400 mg/100mL"}, {"name": "SODIUM CHLORIDE", "strength": "205 mg/100mL"}, {"name": "THREONINE", "strength": "336 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "144 mg/100mL"}, {"name": "TYROSINE", "strength": "32 mg/100mL"}, {"name": "VALINE", "strength": "464 mg/100mL"}], "application_number": "NDA020678", "marketing_category": "NDA", "marketing_start_date": "20200921", "listing_expiration_date": "20261231"}