FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
50268-182
11-digit product format
502680182
Labeler code
50268
Product ID
50268-182_2b48bae3-c39f-1035-e063-6394a90a2cc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
AvPAK
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-06-13
Substance
ANHYDROUS CITRIC ACID; SODIUM CITRATE
Active strength
334; 500 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
Sodium Citrate and Citric Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANHYDROUS CITRIC ACID334 mg/5mL
SODIUM CITRATE500 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Q73Q2JULR, XF417D3PSL
Rxcui543014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-182-11Sodium Citrate and Citric Acid15 mL in 1 CUP, UNIT-DOSESOLUTION152
50268-182-15Sodium Citrate and Citric Acid40 in 1 CARTONSOLUTION402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-182-11ML - Milliliter50268-182e2f69a0a-fdc5-486a-8889-9bbf3bf382b812023-08-08
50268-182-15ML - Milliliter50268-18280a1c9f4-a596-476e-95f1-805beb0d8b0112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-182SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [AVPAK]2Current NDC, 2 package rows20250112_fe070e2e-3e72-fb84-e053-6294a90afd88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSNfe070e2e-3e72-fb84-e053-6294a90afd882
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCDfe070e2e-3e72-fb84-e053-6294a90afd882
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSYfe070e2e-3e72-fb84-e053-6294a90afd882
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSYfe070e2e-3e72-fb84-e053-6294a90afd882
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSYfe070e2e-3e72-fb84-e053-6294a90afd882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-182-115026801821115 mL in 1 CUP, UNIT-DOSE15 mlHistorical
50268-182-155026801821540 CUP, UNIT-DOSE in 1 CARTON (50268-182-15) / 15 mL in 1 CUP, UNIT-DOSE (50268-182-11) 2023-06-13NoNoCurrent