FDA.reportPublic FDA data

Potassium Citrate and Citric Acid

Product NDC
0121-0676
11-digit product format
001210676
Labeler code
0121
Product ID
0121-0676_a89c03e3-61a9-46df-9de7-e73f522f123d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate and Citric Acid Monohydrate
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1997-10-07
Substance
CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE
Active strength
334; 1100 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
Potassium Citrate and Citric Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE334 mg/5mL
CITRIC ACID MONOHYDRATE1100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EE90ONI6FFInternal UNII lookup
2968PHW8QPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309318Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce42122f-8087-471f-b0a3-5524bdbd4526Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0676-16Potassium Citrate and Citric Acid473 mL in 1 BOTTLESOLUTION4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0676-16ML - Milliliter0121-067694c817d6-748b-4708-ad4e-991f733c58ed12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Citric Acid MonohydrateACTIVE INGREDIENT2968PHW8QPPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Potassium CitrateACTIVE INGREDIENTEE90ONI6FFPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSLPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPOTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0676POTASSIUM CITRATE AND CITRIC ACID (POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]6Current NDC, Legacy NDC, 1 package rows20241121_ce42122f-8087-471f-b0a3-5524bdbd4526.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
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
ndc (product): 0121-0676

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309318citric acid 334 MG / potassium citrate 1100 MG in 5 mL Oral SolutionPSNce42122f-8087-471f-b0a3-5524bdbd45266
309318citric acid 66.8 MG/ML / potassium citrate 220 MG/ML Oral SolutionSCDce42122f-8087-471f-b0a3-5524bdbd45266
309318citric acid 334 MG / potassium citrate 1100 MG per 5 ML Oral SolutionSYce42122f-8087-471f-b0a3-5524bdbd45266
309318Citric Acid 66.8 MG/ML / K+ citrate 220 MG/ML Oral SolutionSYce42122f-8087-471f-b0a3-5524bdbd45266
309318Citric Acid 66.8 MG/ML / Pot citrate 220 MG/ML Oral SolutionSYce42122f-8087-471f-b0a3-5524bdbd45266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0676-1600121067616473 mL in 1 BOTTLE (0121-0676-16) 473 ml1997-10-070000-00-00NoNoCurrent