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
CITRIC ACID MONOHYDRATE334 mg/5mL
POTASSIUM CITRATE1100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2968PHW8QP, EE90ONI6FF
Rxcui309318

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

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