SODIUM LACTATE RINGER’S INJECTION

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]

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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

SODIUM LACTATE RINGER’S INJECTION

HEALTH CARE PROFESSIONAL LETTER

DHCP Letter 1.jpg
DHCP Letter 2.jpg

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/).

DHCP Letter 3.jpg
DHCP Letter 4.jpg
DHCP Letter 5.jpg
DHCP Letter 6.jpg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Lactated Ringer Representative Carton Label 500ml Chinese.jpg

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

LACTATED RINGERS 
sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0338-9832
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE600 mg  in 100 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE310 mg  in 100 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE30 mg  in 100 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE20 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0338-9832-2424 in 1 CARTON12/03/202405/26/2025
1NDC: 0338-9832-01500 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage12/03/202405/26/2025
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare (Shanghai) Co. Ltd.527191860ANALYSIS(0338-9832) , LABEL(0338-9832) , MANUFACTURE(0338-9832) , PACK(0338-9832) , STERILIZE(0338-9832)

Revised: 12/2024