FDA.reportPublic FDA data

Potassium Citrate and Citric Acid

Product NDC
68999-435
11-digit product format
689990435
Labeler code
68999
Product ID
68999-435_4baa11c3-daf8-3787-e063-6394a90af88a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate and Citric Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-12-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Citrate and Citric Acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE1100 mg/5mL
CITRIC ACID MONOHYDRATE334 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
fd57a176-7faf-4053-b348-6ba5f192f05aAvailable 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
68999-435-05Potassium Citrate and Citric Acid5 mL in 1 CUPSOLUTION52
68999-435-24Potassium Citrate and Citric Acid2 in 1 BOXSOLUTION22
68999-435-24Potassium Citrate and Citric Acid10 in 1 TRAYSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-435-05ML - Milliliter68999-43562defa7f-529d-4b2e-9a79-38198ba12d6612026-04-20
68999-435-24ML - Milliliter68999-435dc6bae45-bede-4d28-9975-20751ba1b1da12026-04-20

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 ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
ndc (product): 68999-435

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309318citric acid 334 MG / potassium citrate 1100 MG in 5 mL Oral SolutionPSNfd57a176-7faf-4053-b348-6ba5f192f05a2
309318citric acid 66.8 MG/ML / potassium citrate 220 MG/ML Oral SolutionSCDfd57a176-7faf-4053-b348-6ba5f192f05a2
309318citric acid 334 MG / potassium citrate 1100 MG per 5 ML Oral SolutionSYfd57a176-7faf-4053-b348-6ba5f192f05a2
309318Citric Acid 66.8 MG/ML / K+ citrate 220 MG/ML Oral SolutionSYfd57a176-7faf-4053-b348-6ba5f192f05a2
309318Citric Acid 66.8 MG/ML / Pot citrate 220 MG/ML Oral SolutionSYfd57a176-7faf-4053-b348-6ba5f192f05a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-435-05689990435055 mL in 1 CUP5 mlHistorical
68999-435-24689990435242 TRAY in 1 BOX (68999-435-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-435-05) 2 tray2026-02-16NoNoCurrent