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Ringers

Ringer's Injection, USP

Approved
Approval ID

a926f913-18fa-4a3e-bfd6-210e1e427960

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 18, 2021

Manufacturers
FDA

ICU Medical Inc.

DUNS: 118380146

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0990-7982
Application NumberNDA018251
Product Classification
M
Marketing Category
C73594
G
Generic Name
SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 18, 2021
FDA Product Classification

INGREDIENTS (6)

CALCIUM CHLORIDEActive
Quantity: 33 mg in 100 mL
Code: M4I0D6VV5M
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 860 mg in 100 mL
Code: 451W47IQ8X
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 30 mg in 100 mL
Code: 660YQ98I10
Classification: ACTIB

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Ringers - FDA Drug Approval Details