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

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kabiven
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 fresenius kabi usa, llc
Dosage Form INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients

alanine 467 mg/100mL, arginine 330 mg/100mL, aspartic acid 99 mg/100mL, calcium chloride 29 mg/100mL, dextrose monohydrate 10.8 g/100mL, glutamic acid 164 mg/100mL, glycine 231 mg/100mL, histidine 199 mg/100mL, isoleucine 164 mg/100mL, leucine 231 mg/100mL, lysine hydrochloride 263 mg/100mL, magnesium sulfate heptahydrate 96 mg/100mL, methionine 164 mg/100mL, phenylalanine 231 mg/100mL, potassium chloride 174 mg/100mL, proline 199 mg/100mL, serine 131 mg/100mL, sodium acetate 239 mg/100mL, sodium glycerophosphate anhydrous 147 mg/100mL, soybean oil 3.9 g/100mL, threonine 164 mg/100mL, tryptophan 55 mg/100mL, tyrosine 6.7 mg/100mL, valine 213 mg/100mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-712
Product ID 63323-712_f4e7d197-8c8f-4603-ae34-cd4c204d89c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200656
Listing Expiration 2026-12-31
Marketing Start 2014-08-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323712
Hyphenated Format 63323-712

Supplemental Identifiers

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
NUI
N0000175780 M0000922 N0000191261 M0012553

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 kabiven (source: ndc)
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 (source: ndc)
Application Number NDA200656 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 467 mg/100mL
  • 330 mg/100mL
  • 99 mg/100mL
  • 29 mg/100mL
  • 10.8 g/100mL
  • 164 mg/100mL
  • 231 mg/100mL
  • 199 mg/100mL
  • 263 mg/100mL
  • 96 mg/100mL
  • 174 mg/100mL
  • 131 mg/100mL
  • 239 mg/100mL
  • 147 mg/100mL
  • 3.9 g/100mL
  • 55 mg/100mL
  • 6.7 mg/100mL
  • 213 mg/100mL
source: ndc
Packaging
  • 1026 mL in 1 BAG (63323-712-10)
  • 1540 mL in 1 BAG (63323-712-15)
  • 2053 mL in 1 BAG (63323-712-20)
  • 2566 mL in 1 BAG (63323-712-25)
source: ndc

Packages (4)

63323-712-10 1026 mL in 1 BAG (63323-712-10) 63323-712-15 1540 mL in 1 BAG (63323-712-15) 63323-712-20 2053 mL in 1 BAG (63323-712-20) 63323-712-25 2566 mL in 1 BAG (63323-712-25)

Ingredients (24)

alanine (467 mg/100mL) arginine (330 mg/100mL) aspartic acid (99 mg/100mL) calcium chloride (29 mg/100mL) dextrose monohydrate (10.8 g/100mL) glutamic acid (164 mg/100mL) glycine (231 mg/100mL) histidine (199 mg/100mL) isoleucine (164 mg/100mL) leucine (231 mg/100mL) lysine hydrochloride (263 mg/100mL) magnesium sulfate heptahydrate (96 mg/100mL) methionine (164 mg/100mL) phenylalanine (231 mg/100mL) potassium chloride (174 mg/100mL) proline (199 mg/100mL) serine (131 mg/100mL) sodium acetate (239 mg/100mL) sodium glycerophosphate anhydrous (147 mg/100mL) soybean oil (3.9 g/100mL) threonine (164 mg/100mL) tryptophan (55 mg/100mL) tyrosine (6.7 mg/100mL) valine (213 mg/100mL)

Linked Drug Pages (1)

Kabiven ndc-match (0.9)

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"}