Package 63323-712-10
Brand: kabiven
Generic: dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosinePackage Facts
Identity
Package NDC
63323-712-10
Digits Only
6332371210
Product NDC
63323-712
Description
1026 mL in 1 BAG (63323-712-10)
Marketing
Marketing Status
Brand
kabiven
Generic
dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "f4e7d197-8c8f-4603-ae34-cd4c204d89c3", "openfda": {"nui": ["N0000175780", "M0000922", "N0000191261", "M0012553"], "upc": ["0363323712105", "0363323712204", "0363323712150", "0363323712259"], "unii": ["OF5P57N2ZX", "94ZLA3W45F", "30KYC7MIAI", "M4I0D6VV5M", "LX22YL083G", "3KX376GY7L", "TE7660XO1C", "4QD397987E", "04Y7590D77", "GMW67QNF9C", "JNJ23Q2COM", "SK47B8698T", "AE28F7PNPL", "47E5O17Y3R", "660YQ98I10", "9DLQ4CIU6V", "452VLY9402", "4550K0SC9B", "YP1H63LJ2K", "241ATL177A", "2ZD004190S", "8DUH1N11BX", "42HK56048U", "HG18B9YRS7"], "spl_set_id": ["afeb4837-a759-4484-a76e-e04611c459e7"], "pharm_class_cs": ["Amino Acids [CS]", "Lipids [CS]"], "pharm_class_epc": ["Amino Acid [EPC]", "Lipid Emulsion [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1026 mL in 1 BAG (63323-712-10)", "package_ndc": "63323-712-10", "marketing_start_date": "20140825"}, {"sample": false, "description": "1540 mL in 1 BAG (63323-712-15)", "package_ndc": "63323-712-15", "marketing_start_date": "20140825"}, {"sample": false, "description": "2053 mL in 1 BAG (63323-712-20)", "package_ndc": "63323-712-20", "marketing_start_date": "20140825"}, {"sample": false, "description": "2566 mL in 1 BAG (63323-712-25)", "package_ndc": "63323-712-25", "marketing_start_date": "20140825"}], "brand_name": "Kabiven", "product_id": "63323-712_f4e7d197-8c8f-4603-ae34-cd4c204d89c3", "dosage_form": "INJECTION, EMULSION", "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]", "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 Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Lipid Emulsion [EPC]", "Lipids [CS]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Osmotic Laxative [EPC]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]", "Potassium Compounds [CS]", "Potassium Salt [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "63323-712", "generic_name": "Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kabiven", "active_ingredients": [{"name": "ALANINE", "strength": "467 mg/100mL"}, {"name": "ARGININE", "strength": "330 mg/100mL"}, {"name": "ASPARTIC ACID", "strength": "99 mg/100mL"}, {"name": "CALCIUM CHLORIDE", "strength": "29 mg/100mL"}, {"name": "DEXTROSE MONOHYDRATE", "strength": "10.8 g/100mL"}, {"name": "GLUTAMIC ACID", "strength": "164 mg/100mL"}, {"name": "GLYCINE", "strength": "231 mg/100mL"}, {"name": "HISTIDINE", "strength": "199 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "164 mg/100mL"}, {"name": "LEUCINE", "strength": "231 mg/100mL"}, {"name": "LYSINE HYDROCHLORIDE", "strength": "263 mg/100mL"}, {"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "96 mg/100mL"}, {"name": "METHIONINE", "strength": "164 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "231 mg/100mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "174 mg/100mL"}, {"name": "PROLINE", "strength": "199 mg/100mL"}, {"name": "SERINE", "strength": "131 mg/100mL"}, {"name": "SODIUM ACETATE", "strength": "239 mg/100mL"}, {"name": "SODIUM GLYCEROPHOSPHATE ANHYDROUS", "strength": "147 mg/100mL"}, {"name": "SOYBEAN OIL", "strength": "3.9 g/100mL"}, {"name": "THREONINE", "strength": "164 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "55 mg/100mL"}, {"name": "TYROSINE", "strength": "6.7 mg/100mL"}, {"name": "VALINE", "strength": "213 mg/100mL"}], "application_number": "NDA200656", "marketing_category": "NDA", "marketing_start_date": "20140825", "listing_expiration_date": "20261231"}