FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
62135-434
11-digit product format
621350434
Labeler code
62135
Product ID
62135-434_19c45cf2-8b45-3d39-e063-6394a90a6e54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Citrate and Citric Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-12-08
Substance
CITRIC ACID MONOHYDRATE; SODIUM CITRATE
Active strength
334; 500 mg/5mL; mg/5mL
Pharmacologic classes
Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], 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
Sodium Citrate and Citric Acid
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Q73Q2JULR, 2968PHW8QP
Rxcui543014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-434-47Sodium Citrate and Citric Acid473 mL in 1 BOTTLESOLUTION4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-434-47ML - Milliliter62135-4344515dabf-9518-4c6d-9adc-0b4bbb56128212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-434SODIUM CITRATE AND CITRIC ACID SOLUTION [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 1 package rows20240602_525136c9-7758-437b-b57b-94b905786825.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN525136c9-7758-437b-b57b-94b9057868253
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD525136c9-7758-437b-b57b-94b9057868253
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY525136c9-7758-437b-b57b-94b9057868253
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY525136c9-7758-437b-b57b-94b9057868253
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY525136c9-7758-437b-b57b-94b9057868253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-434-4762135043447473 mL in 1 BOTTLE (62135-434-47) 473 ml2022-12-080000-00-00NoNoCurrent