perikabiven

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 perikabiven
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 333 mg/100mL, arginine 235 mg/100mL, aspartic acid 71 mg/100mL, calcium chloride 20 mg/100mL, dextrose monohydrate 7.5 g/100mL, glutamic acid 116 mg/100mL, glycine 164 mg/100mL, histidine 141 mg/100mL, isoleucine 116 mg/100mL, leucine 164 mg/100mL, lysine hydrochloride 187 mg/100mL, magnesium sulfate heptahydrate 68 mg/100mL, methionine 116 mg/100mL, phenylalanine 164 mg/100mL, potassium chloride 124 mg/100mL, proline 141 mg/100mL, serine 94 mg/100mL, sodium acetate 170 mg/100mL, sodium glycerophosphate anhydrous 105 mg/100mL, soybean oil 3.5 g/100mL, threonine 116 mg/100mL, tryptophan 40 mg/100mL, tyrosine 4.8 mg/100mL, valine 152 mg/100mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-714
Product ID 63323-714_40a5c387-1b0a-4e8e-94e1-f045d7281b0b
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 63323714
Hyphenated Format 63323-714

Supplemental Identifiers

UPC
0363323714192 0363323714147
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 perikabiven (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
  • 333 mg/100mL
  • 235 mg/100mL
  • 71 mg/100mL
  • 20 mg/100mL
  • 7.5 g/100mL
  • 116 mg/100mL
  • 164 mg/100mL
  • 141 mg/100mL
  • 187 mg/100mL
  • 68 mg/100mL
  • 124 mg/100mL
  • 94 mg/100mL
  • 170 mg/100mL
  • 105 mg/100mL
  • 3.5 g/100mL
  • 40 mg/100mL
  • 4.8 mg/100mL
  • 152 mg/100mL
source: ndc
Packaging
  • 1440 mL in 1 BAG (63323-714-14)
  • 1920 mL in 1 BAG (63323-714-19)
source: ndc

Packages (2)

63323-714-14 1440 mL in 1 BAG (63323-714-14) 63323-714-19 1920 mL in 1 BAG (63323-714-19)

Ingredients (24)

alanine (333 mg/100mL) arginine (235 mg/100mL) aspartic acid (71 mg/100mL) calcium chloride (20 mg/100mL) dextrose monohydrate (7.5 g/100mL) glutamic acid (116 mg/100mL) glycine (164 mg/100mL) histidine (141 mg/100mL) isoleucine (116 mg/100mL) leucine (164 mg/100mL) lysine hydrochloride (187 mg/100mL) magnesium sulfate heptahydrate (68 mg/100mL) methionine (116 mg/100mL) phenylalanine (164 mg/100mL) potassium chloride (124 mg/100mL) proline (141 mg/100mL) serine (94 mg/100mL) sodium acetate (170 mg/100mL) sodium glycerophosphate anhydrous (105 mg/100mL) soybean oil (3.5 g/100mL) threonine (116 mg/100mL) tryptophan (40 mg/100mL) tyrosine (4.8 mg/100mL) valine (152 mg/100mL)

Linked Drug Pages (1)

Perikabiven ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "40a5c387-1b0a-4e8e-94e1-f045d7281b0b", "openfda": {"nui": ["N0000175780", "M0000922", "N0000191261", "M0012553"], "upc": ["0363323714192", "0363323714147"], "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": ["c2eb5522-8572-45f4-869d-42f9fd251bb6"], "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": "1440 mL in 1 BAG (63323-714-14)", "package_ndc": "63323-714-14", "marketing_start_date": "20140825"}, {"sample": false, "description": "1920 mL in 1 BAG (63323-714-19)", "package_ndc": "63323-714-19", "marketing_start_date": "20140825"}], "brand_name": "Perikabiven", "product_id": "63323-714_40a5c387-1b0a-4e8e-94e1-f045d7281b0b", "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": "63323-714", "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": "Perikabiven", "active_ingredients": [{"name": "ALANINE", "strength": "333 mg/100mL"}, {"name": "ARGININE", "strength": "235 mg/100mL"}, {"name": "ASPARTIC ACID", "strength": "71 mg/100mL"}, {"name": "CALCIUM CHLORIDE", "strength": "20 mg/100mL"}, {"name": "DEXTROSE MONOHYDRATE", "strength": "7.5 g/100mL"}, {"name": "GLUTAMIC ACID", "strength": "116 mg/100mL"}, {"name": "GLYCINE", "strength": "164 mg/100mL"}, {"name": "HISTIDINE", "strength": "141 mg/100mL"}, {"name": "ISOLEUCINE", "strength": "116 mg/100mL"}, {"name": "LEUCINE", "strength": "164 mg/100mL"}, {"name": "LYSINE HYDROCHLORIDE", "strength": "187 mg/100mL"}, {"name": "MAGNESIUM SULFATE HEPTAHYDRATE", "strength": "68 mg/100mL"}, {"name": "METHIONINE", "strength": "116 mg/100mL"}, {"name": "PHENYLALANINE", "strength": "164 mg/100mL"}, {"name": "POTASSIUM CHLORIDE", "strength": "124 mg/100mL"}, {"name": "PROLINE", "strength": "141 mg/100mL"}, {"name": "SERINE", "strength": "94 mg/100mL"}, {"name": "SODIUM ACETATE", "strength": "170 mg/100mL"}, {"name": "SODIUM GLYCEROPHOSPHATE ANHYDROUS", "strength": "105 mg/100mL"}, {"name": "SOYBEAN OIL", "strength": "3.5 g/100mL"}, {"name": "THREONINE", "strength": "116 mg/100mL"}, {"name": "TRYPTOPHAN", "strength": "40 mg/100mL"}, {"name": "TYROSINE", "strength": "4.8 mg/100mL"}, {"name": "VALINE", "strength": "152 mg/100mL"}], "application_number": "NDA200656", "marketing_category": "NDA", "marketing_start_date": "20140825", "listing_expiration_date": "20261231"}