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
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
63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5Available on FDA.report

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

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 MONOHYDRATEPharmaceutical Associates, Inc.63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd52024-11-13Adverse reactionsExact identifier
ndc (product): 0121-0595

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