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_49d43b5b-a437-4827-87b7-5db8286bb14b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1969-01-01
Substance
SODIUM CITRATE; ANHYDROUS CITRIC ACID
Active strength
500; 334 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
SODIUM CITRATE500 mg/5mL
ANHYDROUS CITRIC ACID334 mg/5mL

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