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 Identifiers#

Field, Values table
FieldValues
UniiXF417D3PSL, 1Q73Q2JULR
Rxcui543014

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

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