LACTATED RINGERS- sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution

Lactated Ringers by

Drug Labeling and Warnings

Lactated Ringers by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Healthcare (Shanghai) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CARE PROFESSIONAL LETTER

Please refer to the FDA approved package insert for the full prescribing information of the drug product as
follows:
Lactated Ringer’s Injection, USP (click /DailyMed/dad7735c-709b-40ea-ab7a-15577e24a966)

Reporting Adverse Events or Product Quality Issues

To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-
800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also
be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to
request a reporting form, then complete and return to the address on the pre-addressed form, or submit
by fax to 1-800-FDA-0178 (1-800-332-0178).

To report product quality issues associated with these imported products, please contact Baxter Product
Surveillance through Baxter - Product Feedback Portal (https://productfeedback.baxter.com/).

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Baxter Logo Trademark

A6E2323

SODIUM LACTATE RINGER’S
INJECTION

100

200

300

400

500ml

[Strength] 500ml
Each 500ml contains 1.55g Sodium Lactate,
3.00g Sodium Chloride, 0.15g Potassium Chloride, and 0.10g
Calcium Chloride Dihydrate
[Description] This product is a clear, colorless liquid
[Dosage and Administration] Intravenous drip See the package
insert for details
For details of [Indications], [Adverse Reactions],
[Contraindications], and [Precautions], please refer to the
package insert
[Storage] Store in overwrap
The solution should be clear and should be used
up at one time
Inspect the inner bag by squeezing it and discard
solution if leakage occurs
License Number: H19983144

[Drug Marketing Authorization Holder] [Manufacturer]
Name: Baxter Healthcare (Shanghai) Co., Ltd.
Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

LOT
MFG
EXP

INGREDIENTS AND APPEARANCE

LACTATED RINGERS 
sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9832
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	600 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	SODIUM LACTATE	310 mg  in 100 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)	POTASSIUM CHLORIDE	30 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	20 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9832-24	24 in 1 CARTON	12/03/2024
1	NDC: 0338-9832-01	500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		12/03/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare (Shanghai) Co. Ltd.		527191860	ANALYSIS(0338-9832) , LABEL(0338-9832) , MANUFACTURE(0338-9832) , PACK(0338-9832) , STERILIZE(0338-9832)