FDA.reportPublic FDA data

Potassium Citrate and Citric Acid

Product NDC
62135-435
11-digit product format
621350435
Labeler code
62135
Product ID
62135-435_32598dec-73a0-13fd-e063-6294a90ad1ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Citrate and Citric Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell 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
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 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
978a5a9d-f0ca-4308-a84b-3b132263bbb8Available 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
62135-435-05Potassium Citrate and Citric Acid5 mL in 1 CUPSOLUTION52
62135-435-24Potassium Citrate and Citric Acid2 in 1 BOXSOLUTION22
62135-435-24Potassium Citrate and Citric Acid10 in 1 TRAYSOLUTION102
62135-435-47Potassium Citrate and Citric Acid473 mL in 1 BOTTLESOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-435-05ML - Milliliter62135-4358c08a39a-7f55-4af7-a64f-3b30b520743112025-07-08
62135-435-24ML - Milliliter62135-4358530f1cf-6e37-423c-80a1-26b1cdc6e68a12025-07-08
62135-435-47ML - Milliliter62135-435379f5073-3b22-4a50-a410-3a85665b630f12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-435POTASSIUM CITRATE AND CITRIC ACID SOLUTION [CHARTWELL RX, LLC]2Current NDC, Legacy NDC, 4 package rows20250411_978a5a9d-f0ca-4308-a84b-3b132263bbb8.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 ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
ndc (product): 62135-435

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309318citric acid 334 MG / potassium citrate 1100 MG in 5 mL Oral SolutionPSN978a5a9d-f0ca-4308-a84b-3b132263bbb82
309318citric acid 66.8 MG/ML / potassium citrate 220 MG/ML Oral SolutionSCD978a5a9d-f0ca-4308-a84b-3b132263bbb82
309318citric acid 334 MG / potassium citrate 1100 MG per 5 ML Oral SolutionSY978a5a9d-f0ca-4308-a84b-3b132263bbb82
309318Citric Acid 66.8 MG/ML / K+ citrate 220 MG/ML Oral SolutionSY978a5a9d-f0ca-4308-a84b-3b132263bbb82
309318Citric Acid 66.8 MG/ML / Pot citrate 220 MG/ML Oral SolutionSY978a5a9d-f0ca-4308-a84b-3b132263bbb82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-435-05621350435055 mL in 1 CUP5 mlHistorical
62135-435-24621350435242 TRAY in 1 BOX (62135-435-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-435-05) 2 tray2025-04-04NoNoCurrent
62135-435-4762135043547473 mL in 1 BOTTLE (62135-435-47) 473 ml2022-12-080000-00-00NoNoCurrent