FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
60687-834
11-digit product format
606870834
Labeler code
60687
Product ID
60687-834_1d62bd0d-9703-cbc0-e063-6294a90a7eea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-07-21
Substance
ANHYDROUS CITRIC ACID; SODIUM CITRATE, UNSPECIFIED FORM
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
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
ANHYDROUS CITRIC ACID2004 mg/30mL
SODIUM CITRATE, UNSPECIFIED FORM3000 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXF417D3PSL, 1Q73Q2JULR
Rxcui543014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-834-45Sodium Citrate and Citric Acid30 mL in 1 CUP, UNIT-DOSESOLUTION301
60687-834-51Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION101
60687-834-76Sodium Citrate and Citric Acid10 in 1 CASESOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-834-45ML - Milliliter60687-834886333c0-3b33-4d32-b1c0-397e6bd72efa12024-08-12
60687-834-76ML - Milliliter60687-834c7e3b8c4-fc7b-4332-9cd2-a8bb51c1733612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-834SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20240721_58fa9952-c8ab-4ebb-a073-15cc45f4832a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN58fa9952-c8ab-4ebb-a073-15cc45f4832a1
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD58fa9952-c8ab-4ebb-a073-15cc45f4832a1
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY58fa9952-c8ab-4ebb-a073-15cc45f4832a1
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY58fa9952-c8ab-4ebb-a073-15cc45f4832a1
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY58fa9952-c8ab-4ebb-a073-15cc45f4832a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-834-456068708344530 mL in 1 CUP, UNIT-DOSE30 mlHistorical
60687-834-516068708345110 in 1 TRAYHistorical
60687-834-766068708347610 TRAY in 1 CASE (60687-834-76) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-834-51) / 30 mL in 1 CUP, UNIT-DOSE (60687-834-45) 10 tray2024-07-21NoNoHistorical