FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE334 mg/5mL
POTASSIUM CITRATE550 mg/5mL
SODIUM CITRATE500 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP, EE90ONI6FF, 1Q73Q2JULR
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 tray2026-02-20NoNoHistorical