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
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
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

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