Lactated Ringers and Dextrose

Product NDC
65219-241
11-digit product format
652190241
Labeler code
65219
Product ID
65219-241_b13e4afe-9bf1-4bf8-9674-e53ae5cb0fce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA210332
Marketing category
ANDA
Marketing start
2022-03-28
Substance
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
Active strength
20; 5; 30; 600; 310 mg/100mL; g/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 and Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CHLORIDE20 mg/100mL
DEXTROSE MONOHYDRATE5 g/100mL
POTASSIUM CHLORIDE30 mg/100mL
SODIUM CHLORIDE600 mg/100mL
SODIUM LACTATE310 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X, LX22YL083G, M4I0D6VV5M, 660YQ98I10, TU7HW0W0QT
Rxcui847627

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
65219-241-00Lactated Ringers and Dextrose1000 mL in 1 BAGINJECTION, SOLUTION10005
65219-241-10Lactated Ringers and Dextrose10 in 1 CASEINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-241LACTATED RINGERS AND DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]5Current NDC, 2 package rows20240524_1b912c7e-f005-4af4-b683-083440964249.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847627lactated Ringers with dextrose 5 % Injectable SolutionPSN1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 0.2 MG/ML / glucose 50 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCD1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 0.2 MG/ML / glucose 50 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 0.2 MG/ML / glucose 50 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSY1b912c7e-f005-4af4-b683-0834409642495
847627calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringers with dextrose 5 % Injectable SolutionSY1b912c7e-f005-4af4-b683-0834409642495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-241-00652190241001000 mL in 1 BAG1000 mlHistorical
65219-241-106521902411010 BAG in 1 CASE (65219-241-10) / 1000 mL in 1 BAG (65219-241-00) 10 bag2022-03-28NoNoHistorical