FDA.reportPublic FDA data

Sodium Citrate and Citric Acid

Product NDC
0121-1190
11-digit product format
001211190
Labeler code
0121
Product ID
0121-1190_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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1190-00Sodium Citrate and Citric Acid10 in 1 CASESOLUTION1010
0121-1190-00Sodium Citrate and Citric Acid10 in 1 TRAYSOLUTION1010
0121-1190-30Sodium Citrate and Citric Acid30 mL in 1 CUP, UNIT-DOSESOLUTION3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1190-00ML - Milliliter0121-1190f53a575f-57da-411a-8b6c-354d9bfe3c2d12017-05-03
0121-1190-30ML - Milliliter0121-11902a1f3afe-b13d-42e0-bf3d-ba0f7a6ceda412017-05-03

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
0121-1190SODIUM CITRATE AND CITRIC ACID (SODIUM CITRATE AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]10Current NDC, Legacy NDC, 3 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 SolutionPSNb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 66.8 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCDb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 1002 MG / sodium citrate 1500 MG per 15 ML Oral SolutionSYb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 2004 MG / sodium citrate 3000 MG per 30 ML Oral SolutionSYb3d5225c-0ee4-481e-b9ec-bc5e1321096d6
543014citric acid 334 MG / sodium citrate 500 MG per 5 ML Oral SolutionSYb3d5225c-0ee4-481e-b9ec-bc5e1321096d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1190-000012111900010 TRAY in 1 CASE (0121-1190-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1190-30) 10 tray1969-01-010000-00-00NoNoCurrent
0121-1190-300012111903030 mL in 1 CUP, UNIT-DOSE30 mlHistorical