MedPath
FDA Product

Perikabiven

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Perikabiven

63323-714

Regulatory Information

63323-714

NDA200656

C73594

August 7, 2023

USA

These highlights do not include all the information needed to use PERIKABIVEN safely and effectively. See full prescribing information for PERIKABIVEN. PERIKABIVEN (amino acids, electrolytes, dextrose and lipid injectable emulsion), for intravenous useInitial U.S. Approval: 2014

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

608775388

Active Ingredients

EGG PHOSPHOLIPIDS

Code: 1Z74184RGV

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

SOYBEAN OIL

Quantity: 3.5 g in 100 mL

Code: 241ATL177A

Class Code: ACTIB

SODIUM ACETATE

Quantity: 170 mg in 100 mL

Code: 4550K0SC9B

Class Code: ACTIR

POTASSIUM CHLORIDE

Quantity: 124 mg in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

LYSINE HYDROCHLORIDE

Quantity: 187 mg in 100 mL

Code: JNJ23Q2COM

Class Code: ACTIM

SODIUM GLYCEROPHOSPHATE ANHYDROUS

Quantity: 105 mg in 100 mL

Code: YP1H63LJ2K

Class Code: ACTIB

CALCIUM CHLORIDE

Quantity: 20 mg in 100 mL

Code: M4I0D6VV5M

Class Code: ACTIB

PHENYLALANINE

Quantity: 164 mg in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

LEUCINE

Quantity: 164 mg in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

HISTIDINE

Quantity: 141 mg in 100 mL

Code: 4QD397987E

Class Code: ACTIB

VALINE

Quantity: 152 mg in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

TRYPTOPHAN

Quantity: 40 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

ARGININE

Quantity: 235 mg in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

THREONINE

Quantity: 116 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

METHIONINE

Quantity: 116 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

GLYCINE

Quantity: 164 mg in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

ISOLEUCINE

Quantity: 116 mg in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

ALANINE

Quantity: 333 mg in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

PROLINE

Quantity: 141 mg in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

SERINE

Quantity: 94 mg in 100 mL

Code: 452VLY9402

Class Code: ACTIB

GLUTAMIC ACID

Quantity: 116 mg in 100 mL

Code: 3KX376GY7L

Class Code: ACTIB

ASPARTIC ACID

Quantity: 71 mg in 100 mL

Code: 30KYC7MIAI

Class Code: ACTIB

TYROSINE

Quantity: 4.8 mg in 100 mL

Code: 42HK56048U

Class Code: ACTIB

DEXTROSE MONOHYDRATE

Quantity: 7.5 g in 100 mL

Code: LX22YL083G

Class Code: ACTIB

MAGNESIUM SULFATE HEPTAHYDRATE

Quantity: 68 mg in 100 mL

Code: SK47B8698T

Class Code: ACTIB

Active Moieties

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

SOYBEAN OIL

Code: 241ATL177A

ACETATE ION

Code: 569DQM74SC

PHOSPHATE ION

Code: NK08V8K8HR

LYSINE

Code: K3Z4F929H6

HISTIDINE

Code: 4QD397987E

VALINE

Code: HG18B9YRS7

CHLORIDE ION

Code: Q32ZN48698

MAGNESIUM CATION

Code: T6V3LHY838

PHENYLALANINE

Code: 47E5O17Y3R

LEUCINE

Code: GMW67QNF9C

THREONINE

Code: 2ZD004190S

GLYCINE

Code: TE7660XO1C

ASPARTIC ACID

Code: 30KYC7MIAI

ALANINE

Code: OF5P57N2ZX

ARGININE

Code: 94ZLA3W45F

METHIONINE

Code: AE28F7PNPL

ISOLEUCINE

Code: 04Y7590D77

SERINE

Code: 452VLY9402

TRYPTOPHAN

Code: 8DUH1N11BX

PROLINE

Code: 9DLQ4CIU6V

GLUTAMIC ACID

Code: 3KX376GY7L

TYROSINE

Code: 42HK56048U

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy