Home NDC 81033-017 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS Sodium citrate and citric acid oral solution is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia. To report SUSPECTED ADVERSE REACTIONS, contact Kesin Pharma at 1-833-537-4679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Citrate and Citric Acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANHYDROUS CITRIC ACID 334 mg/5mL SODIUM CITRATE 500 mg/5mL
Harmonized Identifiers# Field, Values table Field Values Unii XF417D3PSL, 1Q73Q2JULR Rxcui 543014
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81033-017-15 Sodium Citrate and Citric Acid 15 mL in 1 CUP, UNIT-DOSE SOLUTION 15 2 81033-017-30 Sodium Citrate and Citric Acid 30 mL in 1 CUP, UNIT-DOSE SOLUTION 30 2 81033-017-50 Sodium Citrate and Citric Acid 100 in 1 CASE SOLUTION 100 2 81033-017-51 Sodium Citrate and Citric Acid 100 in 1 CASE SOLUTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81033-017 SODIUM CITRATE AND CITRIC ACID SOLUTION [KESIN PHARMA CORPORATION] 2 Current NDC, 4 package rows 20250423_3140f8fe-0644-7561-e063-6394a90a2c28.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81033-017-15 81033001715 15 mL in 1 CUP, UNIT-DOSE 15 ml Historical 81033-017-30 81033001730 30 mL in 1 CUP, UNIT-DOSE 30 ml Historical 81033-017-50 81033001750 100 CUP, UNIT-DOSE in 1 CASE (81033-017-50) / 15 mL in 1 CUP, UNIT-DOSE (81033-017-15) 2025-04-01 No No Current 81033-017-51 81033001751 100 CUP, UNIT-DOSE in 1 CASE (81033-017-51) / 30 mL in 1 CUP, UNIT-DOSE (81033-017-30) 2025-04-01 No No Current