Sodium Citrate and Citric Acid

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Sodium Citrate and Citric Acid
Generic name: SODIUM CITRATE AND CITRIC ACID MONOHYDRATE
Manufacturer: Belleview Biosciences LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 3245e0e5-5e7f-c3f7-e063-6394a90ac258
SPL ID: 395a52e7-d488-26c6-e063-6394a90a8158
Version: 2
Effective date: 2025-07-07
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:32:57

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Sodium Citrate and Citric Acid	openfda.brand_name
generic name		SODIUM CITRATE AND CITRIC ACID MONOHYDRATE	openfda.generic_name
manufacturer name		Belleview Biosciences LLC	openfda.manufacturer_name
ndc	package	84447-017-01	openfda.package_ndc
ndc	product	84447-017	openfda.product_ndc
ndc11	package	84447001701	derived:openfda.package_ndc
rxcui		543014	openfda.rxcui
spl id		395a52e7-d488-26c6-e063-6394a90a8158	id
spl set id		3245e0e5-5e7f-c3f7-e063-6394a90ac258	set_id
unii		1Q73Q2JULR	openfda.unii
unii		XF417D3PSL	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Sodium citrate and citric acid oral solution on is generally well tolerated, without any unpleasant side eff ects, when given in recommended doses to patients with normal renal function on and urinary output. However, as with any alkalinizing agent, caution on 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.