FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
0121-0595
11-digit product format
001210595
Labeler code
0121
Product ID
0121-0595_26ce1be6-a69a-63f8-e063-6394a90ad637
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0595-00Sodium Citrate and Citric Acid10 in 1 CASESOLUTION1010
0121-0595-00Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION1010
0121-0595-15Sodium Citrate and Citric Acid15 mL in 1 CUP, UNIT-DOSESOLUTION1510
0121-0595-16Sodium Citrate and Citric Acid473 mL in 1 BOTTLESOLUTION47310
0121-0595-30Sodium Citrate and Citric Acid10 in 1 CASESOLUTION1010
0121-0595-30Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0595-00ML - Milliliter0121-059504f1b315-0b19-43dc-8880-02107f0a444112017-05-03
0121-0595-15ML - Milliliter0121-059539755d14-96ba-449a-974a-ee51f0dad5b512013-02-13
0121-0595-16ML - Milliliter0121-05958504dba4-d1e6-4997-bd8e-7e256ff3034912013-02-13
0121-0595-30ML - Milliliter0121-0595810c9f41-7bae-4f1c-9218-25d078607d7512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPSODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRSODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLSODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RSODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0595SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]10Current NDC, Legacy NDC, 6 package rows20241115_63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543014citric acid 334 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd510
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd510
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSY63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd510
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSY63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd510
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd510
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
0121-0595-000012105950010 TRAY in 1 CASE (0121-0595-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0595-15) 10 tray1969-01-010000-00-00NoNoCurrent
0121-0595-150012105951515 mL in 1 CUP, UNIT-DOSE15 mlHistorical
0121-0595-1600121059516473 mL in 1 BOTTLE (0121-0595-16) 473 ml1969-01-010000-00-00NoNoCurrent
0121-0595-300012105953010 TRAY in 1 CASE (0121-0595-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE10 tray1969-01-010000-00-00NoNoCurrent