FDA Product

Plegisol

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

Basic Information

Product Name

Plegisol

FDA Product Code

0409-7969

Regulatory Information

NDC Product Code

0409-7969

Application Number

NDA018608

Marketing Category

C73594

Effective Date

February 23, 2024

Territorial Authority

USA

FDA Title

PLEGISOL

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

22

Company Information

ManufacturerHospira, Inc.

DUNS Number

141588017

Active Ingredients

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

CALCIUM CHLORIDE

Quantity: 17.6 mg in 100 mL

Code: M4I0D6VV5M

Class Code: ACTIB

MAGNESIUM CHLORIDE

Quantity: 325.3 mg in 100 mL

Code: 02F3473H9O

Class Code: ACTIB

POTASSIUM CHLORIDE

Quantity: 119.3 mg in 100 mL

Code: 660YQ98I10

Class Code: ACTIB

SODIUM CHLORIDE

Quantity: 643 mg in 100 mL

Code: 451W47IQ8X

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CHLORIDE ION

Code: Q32ZN48698

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