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
SODIUM CITRATE500 mg/5mL
CITRIC ACID MONOHYDRATE334 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
543014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
525136c9-7758-437b-b57b-94b905786825Available on FDA.report

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

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
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
ndc (product): 62135-434

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