NDC 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

Perikabiven 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 ID63323-714_7ee1d577-b395-0a1e-e053-2a91aa0a54c1
NDC63323-714
Product TypeHuman Prescription Drug
Proprietary NamePerikabiven
Generic NameDextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine
Dosage FormInjection, Emulsion
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-08-25
Marketing CategoryNDA / NDA
Application NumberNDA200656
Labeler NameFresenius Kabi USA, LLC
Substance NameDEXTROSE 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 Strength7 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 ClassesLipid 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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-714-14

1440 mL in 1 BAG (63323-714-14)
Marketing Start Date2014-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-714-19 [63323071419]

Perikabiven INJECTION, EMULSION
Marketing CategoryNDA
Application NumberNDA200656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-08-25

NDC 63323-714-24 [63323071424]

Perikabiven INJECTION, EMULSION
Marketing CategoryNDA
Application NumberNDA200656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-08-25

NDC 63323-714-14 [63323071414]

Perikabiven INJECTION, EMULSION
Marketing CategoryNDA
Application NumberNDA200656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-08-25

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE6.8 g/100mL

OpenFDA Data

SPL SET ID:c2eb5522-8572-45f4-869d-42f9fd251bb6
Manufacturer
UNII
UPC Code
  • 0077807000069

    • 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 "Perikabiven" 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"

    NDCBrand NameGeneric Name
    63323-714PerikabivenDextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine
    63323-712KabivenDextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine

    Trademark Results [Perikabiven]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PERIKABIVEN
    PERIKABIVEN
    85418843 4637503 Live/Registered
    Fresenius Kabi AG
    2011-09-09
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