Isolyte P in Dextrose
Isolyte P in 5% Dextrose (Multi-Electrolyte Injection)
Approved
Approval ID
4ea4397c-2fa4-4670-91e6-21ae498c88f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2022
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0264-7730
Application NumberNDA019873
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 17, 2022
FDA Product Classification
INGREDIENTS (7)
DEXTROSE MONOHYDRATEActive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.13 g in 100 mL
Code: 660YQ98I10
Classification: ACTIB
POTASSIUM PHOSPHATE, DIBASICActive
Quantity: 0.026 g in 100 mL
Code: CI71S98N1Z
Classification: ACTIB
SODIUM ACETATEActive
Quantity: 0.32 g in 100 mL
Code: 4550K0SC9B
Classification: ACTIB
MAGNESIUM CHLORIDEActive
Quantity: 0.031 g in 100 mL
Code: 02F3473H9O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT