Label: LACTATED RINGERS- sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution
- NDC Code(s): 0338-9832-01, 0338-9832-24
- Packager: Baxter Healthcare Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Unapproved drug for use in drug shortage
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.
Drug Label Information
Updated December 3, 2024
If you are a consumer or patient please visit this version.
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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 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=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
INJECTION100
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, ShanghaiLOT
MFG
EXP -
INGREDIENTS AND APPEARANCE
LACTATED RINGERS
sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solutionProduct 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)