FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
68999-868
11-digit product format
689990868
Labeler code
68999
Product ID
68999-868_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
1002; 1500 mg/15mL; mg/15mL
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
CITRIC ACID MONOHYDRATE1002 mg/15mL
SODIUM CITRATE1500 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP, 1Q73Q2JULR
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
68999-868-24Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION102
68999-868-24Sodium Citrate and Citric Acid2 in 1 BOXSOLUTION22
68999-868-51Sodium Citrate and Citric Acid15 mL in 1 CUPSOLUTION152

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
68999-868-24689990868242 TRAY in 1 BOX (68999-868-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-868-51) 2 tray2026-03-04NoNoHistorical
68999-868-516899908685115 mL in 1 CUP15 mlHistorical