Tricitrates

Product NDC
68999-438
11-digit product format
689990438
Labeler code
68999
Product ID
68999-438_4ba9f5db-6623-7e1a-e063-6294a90a1fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tricitrates
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-12-08
Substance
CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE; SODIUM CITRATE
Active strength
334; 550; 500 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Acidifying Activity [MoA], Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

PRECAUTIONS AND WARNINGS Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Tricitrates oral solution is generally well tolerated without any unpleasant side effects when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.

Additional Listing Data#

Finished product
Yes
Brand name base
Tricitrates
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE334 mg/5mL
SODIUM CITRATE550 mg/5mL
CITRIC ACID MONOHYDRATE500 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE90ONI6FF, 1Q73Q2JULR, 2968PHW8QP
Rxcui309317

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-438-05Tricitrates5 mL in 1 CUPSOLUTION51
68999-438-24Tricitrates2 in 1 BOXSOLUTION21
68999-438-24Tricitrates10 in 1 TRAYSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-438-05ML - Milliliter68999-43876971cbb-a243-4ac9-948b-b9d3be340cdf12026-04-20
68999-438-24ML - Milliliter68999-438b95c5b55-4aa3-43e3-aa4f-acca7c3691fc12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSNc4ff0407-3930-4c48-afd4-d2cb3e1b18f41
309317citric acid 66.8 MG/ML / potassium citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCDc4ff0407-3930-4c48-afd4-d2cb3e1b18f41
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG per 5 ML Oral SolutionSYc4ff0407-3930-4c48-afd4-d2cb3e1b18f41
309317Citric Acid 66.8 MG/ML / K+ citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSYc4ff0407-3930-4c48-afd4-d2cb3e1b18f41
309317Citric Acid 66.8 MG/ML / Pot citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSYc4ff0407-3930-4c48-afd4-d2cb3e1b18f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-438-05689990438055 mL in 1 CUP5 mlHistorical
68999-438-24689990438242 TRAY in 1 BOX (68999-438-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-438-05) 2 tray2026-02-20NoNoCurrent