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
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
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#

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

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): 0121-1190

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