Sodium Citrate and Citric Acid

Product NDC
17856-0595
11-digit product format
178560595
Labeler code
17856
Product ID
17856-0595_4974ca9f-b5e3-870d-e063-6294a90a26c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1969-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Citrate and Citric Acid
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXF417D3PSL, 1Q73Q2JULR
Rxcui543014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0595-1Sodium Citrate and Citric Acid15 mL in 1 CUP, UNIT-DOSESOLUTION158
17856-0595-1Sodium Citrate and Citric Acid72 in 1 CASESOLUTION728
17856-0595-3Sodium Citrate and Citric Acid30 mL in 1 CUPSOLUTION308
17856-0595-3Sodium Citrate and Citric Acid50 in 1 CASESOLUTION508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0595SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [ATLANTIC BIOLOGICALS CORP.]7Current NDC, Legacy NDC, 4 package rows20250525_42d837ae-2578-46df-92d2-24774964aaad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN42d837ae-2578-46df-92d2-24774964aaad8
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD42d837ae-2578-46df-92d2-24774964aaad8
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY42d837ae-2578-46df-92d2-24774964aaad8
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY42d837ae-2578-46df-92d2-24774964aaad8
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY42d837ae-2578-46df-92d2-24774964aaad8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0595-11785605950172 CUP, UNIT-DOSE in 1 CASE (17856-0595-1) / 15 mL in 1 CUP, UNIT-DOSE2024-04-18NoNoHistorical
17856-0595-31785605950350 CUP in 1 CASE (17856-0595-3) / 30 mL in 1 CUP50 cup2024-04-180000-00-00NoNoCurrent
17856-0595-4178560595041 CASE in 1 CUP, UNIT-DOSE (17856-0595-4) > 50 CUP in 1 CASE (17856-0595-3) > 30 mL in 1 CUP1 case2022-09-020000-00-00NoNoCurrent
17856-0595-5178560595051 CASE in 1 CUP, UNIT-DOSE (17856-0595-5) > 72 CUP, UNIT-DOSE in 1 CASE (17856-0595-1) > 15 mL in 1 CUP, UNIT-DOSE1 case2022-09-020000-00-00NoNoCurrent