Lactated Ringers
Lactated Ringer’s Irrigationin ARTHROMATIC Plastic Container
Approved
Approval ID
5215ec33-8cfe-4885-ae92-e6a12100bd27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2018
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium chloride, soldium lactate, potassium chloride and calcium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-0137
Application NumberNDA018921
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium chloride, soldium lactate, potassium chloride and calcium chloride
Product Specifications
Route of AdministrationIRRIGATION
Effective DateSeptember 29, 2015
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEActive
Quantity: 6 g in 1000 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 3.1 g in 1000 mL
Code: TU7HW0W0QT
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 300 mg in 1000 mL
Code: 660YQ98I10
Classification: ACTIB
CALCIUM CHLORIDEActive
Quantity: 200 mg in 1000 mL
Code: M4I0D6VV5M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT