Tricitrates

Product NDC
62135-438
11-digit product format
621350438
Labeler code
62135
Product ID
62135-438_33d7941b-0652-9528-e063-6394a90a8a55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tricitrates
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-438-05Tricitrates5 mL in 1 CUPSOLUTION56
62135-438-24Tricitrates10 in 1 TRAYSOLUTION106
62135-438-24Tricitrates2 in 1 BOXSOLUTION26
62135-438-47Tricitrates473 mL in 1 BOTTLESOLUTION4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-438-05ML - Milliliter62135-438f9bcf808-2c1d-4176-929a-69695b52504c12025-05-14
62135-438-24ML - Milliliter62135-43865653493-a074-4656-84b6-7e3db13cda5812025-05-14
62135-438-47ML - Milliliter62135-438129d2930-641c-40df-bb31-1946217e3ea012023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-438TRICITRATES SOLUTION [CHARTWELL RX, LLC]6Current NDC, Legacy NDC, 4 package rows20250429_2a80ea6b-6334-4c33-a35e-a5cb2939fbcb.zip

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 SolutionPSN2a80ea6b-6334-4c33-a35e-a5cb2939fbcb6
309317citric acid 66.8 MG/ML / potassium citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD2a80ea6b-6334-4c33-a35e-a5cb2939fbcb6
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY2a80ea6b-6334-4c33-a35e-a5cb2939fbcb6
309317Citric Acid 66.8 MG/ML / K+ citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSY2a80ea6b-6334-4c33-a35e-a5cb2939fbcb6
309317Citric Acid 66.8 MG/ML / Pot citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSY2a80ea6b-6334-4c33-a35e-a5cb2939fbcb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-438-05621350438055 mL in 1 CUP5 mlHistorical
62135-438-24621350438242 TRAY in 1 BOX (62135-438-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-438-05) 2 tray2025-04-15NoNoCurrent
62135-438-4762135043847473 mL in 1 BOTTLE (62135-438-47) 473 ml2022-12-080000-00-00NoNoCurrent