MedPath

Lactated Ringers

Lactated Ringer's Irrigation

Approved
Approval ID

a9910e09-5aea-4ee1-a35e-ae4abf8b80b4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 7, 2023

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.

Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride

PRODUCT DETAILS

NDC Product Code0264-2203
Application NumberNDA018681
Marketing CategoryC73594
Route of AdministrationIRRIGATION
Effective DateSeptember 11, 2023
Generic NameSodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride

INGREDIENTS (5)

SODIUM LACTATEActive
Quantity: 0.31 g in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 0.6 g in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 0.03 g in 100 mL
Code: 660YQ98I10
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CALCIUM CHLORIDEActive
Quantity: 0.02 g in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB

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Lactated Ringers - FDA Drug Approval Details