- Product NDC
- 0338-7034
- 11-digit product format
- 003387034
- Labeler code
- 0338
- Product ID
- 0338-7034_dc7ce216-a4a9-41cf-80e3-5e901b8cecdf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary 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
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Company
- Application
- NDA020678
- Marketing category
- NDA
- Marketing start
- 2024-07-15
- Substance
- ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE
- Active strength
- 1035; 575; 33; 20; 515; 240; 300; 365; 290; 51; 200; 280; 261; 340; 250; 340; 59; 210; 90; 20; 290 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes