LACTATED RINGERS

Product NDC
65219-477
11-digit product format
652190477
Labeler code
65219
Product ID
65219-477_78fe11b2-93f0-4243-9e96-f87a2e30d873
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA209338
Marketing category
ANDA
Marketing start
2019-01-28
Substance
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength
20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LACTATED RINGERS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CHLORIDE20 mg/100mL
POTASSIUM CHLORIDE30 mg/100mL
SODIUM CHLORIDE600 mg/100mL
SODIUM LACTATE310 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM4I0D6VV5M, TU7HW0W0QT, 451W47IQ8X, 660YQ98I10
Rxcui847630

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-477-05LACTATED RINGERS500 mL in 1 BAGINJECTION, SOLUTION5002
65219-477-20LACTATED RINGERS20 in 1 CASEINJECTION, SOLUTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-477-05ML - Milliliter65219-477927ce230-dfd9-40ad-80b3-d51703911e2c12024-12-10
65219-477-20ML - Milliliter65219-4774d9971f1-14ed-4887-b203-c117ac6d82b912024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-477LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, 2 package rows20241019_8fce1477-991f-4b43-bf05-a80bad897262.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847630lactated Ringers Injectable SolutionPSN8fce1477-991f-4b43-bf05-a80bad8972622
847630calcium chloride 0.2 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCD8fce1477-991f-4b43-bf05-a80bad8972622
847630calcium chloride 0.2 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY8fce1477-991f-4b43-bf05-a80bad8972622
847630calcium chloride 0.2 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY8fce1477-991f-4b43-bf05-a80bad8972622
847630calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringer's Injectable SolutionSY8fce1477-991f-4b43-bf05-a80bad8972622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-477-0565219047705500 mL in 1 BAG500 mlHistorical
65219-477-206521904772020 BAG in 1 CASE (65219-477-20) / 500 mL in 1 BAG (65219-477-05) 20 bag2019-01-28NoNoCurrent