FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
68999-869
11-digit product format
689990869
Labeler code
68999
Product ID
68999-869_4ee6bc22-bf74-ee36-e063-6394a90a268b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Citrate and Citric Acid
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; SODIUM CITRATE
Active strength
2004; 3000 mg/30mL; mg/30mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Citrate and Citric Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CITRATE3000 mg/30mL
CITRIC ACID MONOHYDRATE2004 mg/30mL

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
58c24504-47de-487a-ab8d-18add155ea95Available 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
68999-869-24Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION102
68999-869-24Sodium Citrate and Citric Acid2 in 1 BOXSOLUTION22
68999-869-43Sodium Citrate and Citric Acid30 mL in 1 CUPSOLUTION302

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 Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
ndc (product): 68999-869

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN58c24504-47de-487a-ab8d-18add155ea952
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD58c24504-47de-487a-ab8d-18add155ea952
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY58c24504-47de-487a-ab8d-18add155ea952
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY58c24504-47de-487a-ab8d-18add155ea952
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY58c24504-47de-487a-ab8d-18add155ea952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-869-24689990869242 TRAY in 1 BOX (68999-869-24) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (68999-869-43) 2 tray2026-03-04NoNoCurrent
68999-869-436899908694330 mL in 1 CUP30 mlHistorical