NDC 63323-712

Kabiven

Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine

Kabiven is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Dextrose Monohydrate; Soybean Oil; Sodium Acetate; Potassium Chloride; Sodium Glycerophosphate Anhydrous; Magnesium Sulfate Heptahydrate; Calcium Chloride; Lysine Hydrochloride; Phenylalanine; Leucine; Valine; Threonine; Methionine; Isoleucine; Tryptophan; Alanine; Arginine; Glycine; Proline; Histidine; Glutamic Acid; Serine; Aspartic Acid; Tyrosine.

• Product ID: 63323-712_7ee1fec0-5516-98c5-e053-2991aa0a8d26
• NDC: 63323-712
• Product Type: Human Prescription Drug
• Proprietary 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
• Dosage Form: Injection, Emulsion
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-08-25
• Marketing Category: NDA / NDA
• Application Number: NDA200656
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; HISTIDINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE
• Active Ingredient Strength: 10 g/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; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
• Pharm Classes: Lipid Emulsion [EPC],Lipids [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Amino Acid [EPC],Amino Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63323-712-10

1026 mL in 1 BAG (63323-712-10)

• Marketing Start Date: 2014-08-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-712-15 [63323071215]

Kabiven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA200656
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-25

NDC 63323-712-25 [63323071225]

Kabiven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA200656
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-25

NDC 63323-712-10 [63323071210]

Kabiven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA200656
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-25

NDC 63323-712-20 [63323071220]

Kabiven INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA200656
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-25

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROSE MONOHYDRATE	9.8 g/100mL

OpenFDA Data

• SPL SET ID: afeb4837-a759-4484-a76e-e04611c459e7
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • AE28F7PNPL
  • M4I0D6VV5M
  • JNJ23Q2COM
  • YP1H63LJ2K
  • LX22YL083G
  • 47E5O17Y3R
  • 4QD397987E
  • GMW67QNF9C
  • HG18B9YRS7
  • 241ATL177A
  • 8DUH1N11BX
  • 9DLQ4CIU6V
  • 04Y7590D77
  • OF5P57N2ZX
  • 2ZD004190S
  • 3KX376GY7L
  • SK47B8698T
  • 30KYC7MIAI
  • 660YQ98I10
  • 42HK56048U
  • TE7660XO1C
  • 94ZLA3W45F
  • 4550K0SC9B
  • 452VLY9402

Pharmacological Class

• Lipid Emulsion [EPC]
• Lipids [CS]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Potassium Compounds [CS]
• Potassium Salt [EPC]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Magnesium Ion Exchange Activity [MoA]
• Osmotic Laxative [EPC]
• Osmotic Activity [MoA]
• Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
• Increased Large Intestinal Motility [PE]
• Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• Amino Acid [EPC]
• Amino Acids [CS]
• Lipid Emulsion [EPC]
• Lipids [CS]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Potassium Compounds [CS]
• Potassium Salt [EPC]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Magnesium Ion Exchange Activity [MoA]
• Osmotic Laxative [EPC]
• Osmotic Activity [MoA]
• Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
• Increased Large Intestinal Motility [PE]
• Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• Amino Acid [EPC]
• Amino Acids [CS]

NDC Crossover Matching brand name "Kabiven" or 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"

NDC	Brand Name	Generic Name
63323-712	Kabiven	Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine
63323-714	Perikabiven	Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine