MedPath

LACTATED RINGERS

LACTATED RINGER'S INJECTION, USP 1000mL BAG

Approved
Approval ID

a14ca7d9-de30-a303-e053-2a95a90a5304

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 27, 2024

Manufacturers
FDA

HF Acquisition Co LLC, DBA HealthFirst

DUNS: 045657305

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, CALCIUM CHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51662-1516
Application NumberNDA017641
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 27, 2024
FDA Product Classification

INGREDIENTS (6)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 600 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
SODIUM LACTATEActive
Quantity: 310 mg in 100 mL
Code: TU7HW0W0QT
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CALCIUM CHLORIDEActive
Quantity: 20 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

LACTATED RINGERS - FDA Drug Approval Details