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
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
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

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 tray2026-02-16NoNoHistorical