FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
84447-017
11-digit product format
844470017
Labeler code
84447
Product ID
84447-017_395a52e7-d488-26c6-e063-6394a90a8158
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Belleview Biosciences LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-08
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
SODIUM CITRATE500 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
3245e0e5-5e7f-c3f7-e063-6394a90ac258Available 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84447-017-01Sodium Citrate and Citric Acid200000 mL in 1 DRUMSOLUTION2000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84447-017SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [BELLEVIEW BIOSCIENCES LLC]1Current NDC, 1 package rows20250410_3245e0e5-5e7f-c3f7-e063-6394a90ac258.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 MONOHYDRATEBelleview Biosciences LLC3245e0e5-5e7f-c3f7-e063-6394a90ac2582025-07-07Adverse reactionsExact identifier
ndc (product): 84447-017

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 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN3245e0e5-5e7f-c3f7-e063-6394a90ac2582
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD3245e0e5-5e7f-c3f7-e063-6394a90ac2582
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY3245e0e5-5e7f-c3f7-e063-6394a90ac2582
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY3245e0e5-5e7f-c3f7-e063-6394a90ac2582
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY3140f8fe-0644-7561-e063-6394a90a2c282
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY3245e0e5-5e7f-c3f7-e063-6394a90ac2582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84447-017-0184447001701200000 mL in 1 DRUM (84447-017-01) 200000 ml2025-04-08NoNoCurrent