FDA.reportPublic FDA data

Lactated Ringers

Product NDC
0990-7953
11-digit product format
009907953
Labeler code
0990
Product ID
0990-7953_179fea68-7eed-4293-b82f-24139e112240
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA017641
Marketing category
NDA
Marketing start
2019-06-24
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
UniiLX22YL083G, 451W47IQ8X, 660YQ98I10, M4I0D6VV5M, TU7HW0W0QT
Rxcui847627, 847630

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
0990-7953-02Lactated Ringers1 in 1 POUCHINJECTION, SOLUTION116
0990-7953-02Lactated Ringers24 in 1 CASEINJECTION, SOLUTION2416
0990-7953-03Lactated Ringers1 in 1 POUCHINJECTION, SOLUTION116
0990-7953-03Lactated Ringers24 in 1 CASEINJECTION, SOLUTION2416
0990-7953-09Lactated Ringers1 in 1 POUCHINJECTION, SOLUTION116
0990-7953-09Lactated Ringers12 in 1 CASEINJECTION, SOLUTION1216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7953-02ML - Milliliter0990-7953042dbc2b-b281-4d6b-8ec6-fddf8129203012020-07-13
0990-7953-03ML - Milliliter0990-7953f60d3534-b3a3-4e6d-b659-38625b5702c412021-04-08
0990-7953-09ML - Milliliter0990-7953e59c106c-7706-4e1b-9d79-4e572587e93d12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7953LACTATED RINGERS AND DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.]13Current NDC, Legacy NDC, 6 package rows20231202_d310d170-5eeb-471b-af1a-0e845001d21d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847630lactated Ringers Injectable SolutionPSNd310d170-5eeb-471b-af1a-0e845001d21d16
847627lactated Ringers with dextrose 5 % Injectable SolutionPSNd310d170-5eeb-471b-af1a-0e845001d21d16
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 SolutionSCDd310d170-5eeb-471b-af1a-0e845001d21d16
847630calcium chloride 0.2 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCDd310d170-5eeb-471b-af1a-0e845001d21d16
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 SolutionSYd310d170-5eeb-471b-af1a-0e845001d21d16
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 SolutionSYd310d170-5eeb-471b-af1a-0e845001d21d16
847630calcium chloride 0.2 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSYd310d170-5eeb-471b-af1a-0e845001d21d16
847630calcium chloride 0.2 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSYd310d170-5eeb-471b-af1a-0e845001d21d16
847630calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringer's Injectable SolutionSYd310d170-5eeb-471b-af1a-0e845001d21d16
847627calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringers with dextrose 5 % Injectable SolutionSYd310d170-5eeb-471b-af1a-0e845001d21d16
847630lactated Ringers Injectable SolutionPSNa14ca7d9-de30-a303-e053-2a95a90a53042
847630calcium chloride 0.2 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCDa14ca7d9-de30-a303-e053-2a95a90a53042
847630calcium chloride 0.2 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSYa14ca7d9-de30-a303-e053-2a95a90a53042
847630calcium chloride 0.2 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSYa14ca7d9-de30-a303-e053-2a95a90a53042
847630calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringer's Injectable SolutionSYa14ca7d9-de30-a303-e053-2a95a90a53042
847630lactated Ringers Injectable SolutionPSNafac6cc5-1ced-4639-b6f6-86f40ef5c30e1
847630calcium chloride 0.2 MG/ML / potassium chloride 0.3 MG/ML / sodium chloride 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSCDafac6cc5-1ced-4639-b6f6-86f40ef5c30e1
847630calcium chloride 0.2 MG/ML / K+ chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSYafac6cc5-1ced-4639-b6f6-86f40ef5c30e1
847630calcium chloride 0.2 MG/ML / Pot chloride 0.3 MG/ML / NaCl 6 MG/ML / sodium lactate 3.1 MG/ML Injectable SolutionSYafac6cc5-1ced-4639-b6f6-86f40ef5c30e1
847630calcium chloride 20 MG / potassium chloride 30 MG / sodium chloride 600 MG / sodium lactate 310 MG per 100 ML Ringer's Injectable SolutionSYafac6cc5-1ced-4639-b6f6-86f40ef5c30e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7953-020099079530224 POUCH in 1 CASE (0990-7953-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG24 pouch2019-06-240000-00-00NoNoCurrent
0990-7953-030099079530324 POUCH in 1 CASE (0990-7953-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG24 pouch2019-08-010000-00-00NoNoCurrent
0990-7953-090099079530912 POUCH in 1 CASE (0990-7953-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG12 pouch2019-08-010000-00-00NoNoCurrent