FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
55154-5777
11-digit product format
551545777
Labeler code
55154
Product ID
55154-5777_a353aa10-ff43-4404-b837-26772d500f9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1969-01-01
Substance
ANHYDROUS CITRIC ACID; SODIUM CITRATE, UNSPECIFIED FORM
Active strength
334; 500 mg/5mL; mg/5mL
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CITRATE, UNSPECIFIED FORM500 mg/5mL
ANHYDROUS CITRIC ACID334 mg/5mL

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
b3d5225c-0ee4-481e-b9ec-bc5e1321096dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5777-5Sodium Citrate and Citric Acid5 in 1 BAGSOLUTION56
55154-5777-5Sodium Citrate and Citric Acid30 mL in 1 CUP, UNIT-DOSESOLUTION306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5777SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [CARDINAL HEALTH 107, LLC]5Current NDC, Legacy NDC, 2 package rows20241222_b3d5225c-0ee4-481e-b9ec-bc5e1321096d.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 MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
ndc (product): 55154-5777

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSNb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCDb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSYb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSYb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSYb3d5225c-0ee4-481e-b9ec-bc5e1321096d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-5777-5551545777055 CUP, UNIT-DOSE in 1 BAG (55154-5777-5) / 30 mL in 1 CUP, UNIT-DOSE1969-01-010000-00-00NoNoCurrent