FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
81033-017
11-digit product format
810330017
Labeler code
81033
Product ID
81033-017_334a40cd-5521-39e3-e063-6394a90ab024
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Citrate and Citric Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-01
Substance
ANHYDROUS CITRIC ACID; SODIUM CITRATE
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANHYDROUS CITRIC ACID334 mg/5mL
SODIUM CITRATE500 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XF417D3PSLInternal UNII lookup
1Q73Q2JULRInternal 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
3140f8fe-0644-7561-e063-6394a90a2c28Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-017-15Sodium Citrate and Citric Acid15 mL in 1 CUP, UNIT-DOSESOLUTION152
81033-017-30Sodium Citrate and Citric Acid30 mL in 1 CUP, UNIT-DOSESOLUTION302
81033-017-50Sodium Citrate and Citric Acid100 in 1 CASESOLUTION1002
81033-017-51Sodium Citrate and Citric Acid100 in 1 CASESOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-017-15ML - Milliliter81033-017d71d3e6f-9708-447d-982f-15aeb8b0896712025-06-13
81033-017-30ML - Milliliter81033-0172bf16df5-7032-4061-9581-24b955a8d28912025-06-13
81033-017-50ML - Milliliter81033-01703502d7f-5933-4a96-bb67-60c856a0056e12025-06-13
81033-017-51ML - Milliliter81033-0179adbc666-1d37-4393-aff6-758b3f42f4a312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-017SODIUM CITRATE AND CITRIC ACID SOLUTION [KESIN PHARMA CORPORATION]2Current NDC, 4 package rows20250423_3140f8fe-0644-7561-e063-6394a90a2c28.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 ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
ndc (product): 81033-017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY3140f8fe-0644-7561-e063-6394a90a2c282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-017-158103300171515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
81033-017-308103300173030 mL in 1 CUP, UNIT-DOSE30 mlHistorical
81033-017-5081033001750100 CUP, UNIT-DOSE in 1 CASE (81033-017-50) / 15 mL in 1 CUP, UNIT-DOSE (81033-017-15) 2025-04-01NoNoCurrent
81033-017-5181033001751100 CUP, UNIT-DOSE in 1 CASE (81033-017-51) / 30 mL in 1 CUP, UNIT-DOSE (81033-017-30) 2025-04-01NoNoCurrent