FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
60687-832
11-digit product format
606870832
Labeler code
60687
Product ID
60687-832_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
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
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 ACID1002 mg/15mL
SODIUM CITRATE, UNSPECIFIED FORM1500 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXF417D3PSL, 1Q73Q2JULR
Rxcui543014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-832-16Sodium Citrate and Citric Acid10 in 1 CASESOLUTION101
60687-832-44Sodium Citrate and Citric Acid15 mL in 1 CUP, UNIT-DOSESOLUTION151
60687-832-50Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-832-16ML - Milliliter60687-832c1045389-b61b-41f2-bf9a-f101286b5a4a12024-08-12
60687-832-44ML - Milliliter60687-832ff1522ec-1a14-4b6e-a973-d4b4fbd2a09c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-832SODIUM 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
60687-832-166068708321610 TRAY in 1 CASE (60687-832-16) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-832-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-832-44) 10 tray2024-07-21NoNoHistorical
60687-832-446068708324415 mL in 1 CUP, UNIT-DOSE15 mlHistorical
60687-832-506068708325010 in 1 TRAYHistorical