Physiolyte

Basic Information

Product Name

Physiolyte

FDA Product Code

0264-2205

Regulatory Information

NDC Product Code

0264-2205

Application Number

NDA019024

Marketing Category

C73594

Effective Date

September 26, 2023

Territorial Authority

USA

FDA Title

Y36-002-961 LD-515-2 Package Insert

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM GLUCONATE

Quantity: 0.5 g in 100 mL

Code: R6Q3791S76

Class Code: ACTIB

POTASSIUM CHLORIDE

Quantity: 0.037 g in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 0.53 g in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

MAGNESIUM CHLORIDE

Quantity: 0.03 g in 100 mL

Code: 02F3473H9O

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

ACETIC ACID

Code: Q40Q9N063P

Class Code: IACT

SODIUM ACETATE

Quantity: 0.37 g in 100 mL

Code: 4550K0SC9B

Class Code: ACTIB

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

ACETATE ION

Code: 569DQM74SC

GLUCONIC ACID

Code: R4R8J0Q44B

Basic Information

Regulatory Information

Company Information

Active Ingredients

WATER

ACETIC ACID

Active Moieties

CHLORIDE ION

ACETATE ION

GLUCONIC ACID