FDA.reportPublic FDA data

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
POTASSIUM CITRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE
Active strength
550; 500; 334 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EE90ONI6FFInternal UNII lookup
1Q73Q2JULRInternal UNII lookup
2968PHW8QPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309317Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a80ea6b-6334-4c33-a35e-a5cb2939fbcbAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
ndc (product): 62135-438

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