FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
50268-183
11-digit product format
502680183
Labeler code
50268
Product ID
50268-183_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
SODIUM CITRATE500 mg/5mL
ANHYDROUS CITRIC ACID334 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Q73Q2JULRInternal UNII lookup
XF417D3PSLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
543014Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe070e2e-3e72-fb84-e053-6294a90afd88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-183-11Sodium Citrate and Citric Acid30 mL in 1 CUP, UNIT-DOSESOLUTION302
50268-183-30Sodium Citrate and Citric Acid40 in 1 CARTONSOLUTION402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-183-11ML - Milliliter50268-183cc0569e9-e12e-411d-b098-1413913c92f012023-08-08
50268-183-30ML - Milliliter50268-183ec5a24a3-81bf-466c-a29f-bb7ea6f3e47f12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-183SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [AVPAK]2Current NDC, 2 package rows20250112_fe070e2e-3e72-fb84-e053-6294a90afd88.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
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
ndc (product): 50268-183

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
50268-183-115026801831130 mL in 1 CUP, UNIT-DOSE30 mlHistorical
50268-183-305026801833040 CUP, UNIT-DOSE in 1 CARTON (50268-183-30) / 30 mL in 1 CUP, UNIT-DOSE (50268-183-11) 2023-06-13NoNoCurrent