Lactated Ringers and Dextrose

Basic Information

Product Name

FDA Product Code

65219-241

Regulatory Information

NDC Product Code

65219-241

Application Number

ANDA210332

Marketing Category

C73584

Effective Date

April 1, 2022

Territorial Authority

USA

FDA Title

LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM LACTATE

Quantity: 310 mg in 100 mL

Code: TU7HW0W0QT

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 600 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

DEXTROSE MONOHYDRATE

Quantity: 5 g in 100 mL

Code: LX22YL083G

Class Code: ACTIB

Water

Code: 059QF0KO0R

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

POTASSIUM CHLORIDE

Quantity: 30 mg in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

CALCIUM CHLORIDE

Quantity: 20 mg in 100 mL

Code: M4I0D6VV5M

Class Code: ACTIB

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

LACTIC ACID, UNSPECIFIED FORM

Code: 33X04XA5AT

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

Basic Information

Regulatory Information

Company Information

Active Ingredients

Water

HYDROCHLORIC ACID

Active Moieties

CHLORIDE ION

LACTIC ACID, UNSPECIFIED FORM

ANHYDROUS DEXTROSE