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
SODIUM CITRATE, UNSPECIFIED FORM1500 mg/15mL
ANHYDROUS CITRIC ACID1002 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Q73Q2JULRInternal UNII lookup
XF417D3PSLInternal 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
58fa9952-c8ab-4ebb-a073-15cc45f4832aAvailable on FDA.report

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

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 ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
ndc (product): 60687-832

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 tray2024-07-21NoNoCurrent
60687-832-446068708324415 mL in 1 CUP, UNIT-DOSE15 mlHistorical
60687-832-506068708325010 in 1 TRAYHistorical