FDA.reportPublic FDA data

TRICITRATES

Product NDC
0121-0677
11-digit product format
001210677
Labeler code
0121
Product ID
0121-0677_3082f36b-0006-4aee-9019-38995d2292fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POTASSIUM CITRATE, 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
2005-05-25
Substance
CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE; SODIUM CITRATE
Active strength
334; 550; 500 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Acidifying Activity [MoA], Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], 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
TRICITRATES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CITRATE334 mg/5mL
SODIUM CITRATE550 mg/5mL
CITRIC ACID MONOHYDRATE500 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EE90ONI6FFInternal UNII lookup
1Q73Q2JULRInternal UNII lookup
2968PHW8QPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309317Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ecb42a2-82f1-456b-8f1e-02c2d0a7b5adAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0677-16TRICITRATES473 mL in 1 BOTTLESOLUTION4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0677-16ML - Milliliter0121-0677dede80bd-4a6a-49f8-8397-6a4f798ef8bf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPTRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
POTASSIUM CITRATEACTIVE INGREDIENTEE90ONI6FFTRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SODIUM CITRATEACTIVE INGREDIENT1Q73Q2JULRTRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLTRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RTRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTRICITRATES (POTASSIUM CITRATE, 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
0121-0677TRICITRATES (POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]6Current NDC, Legacy NDC, 1 package rows20241116_2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad.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
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
ndc (product): 0121-0677

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSN2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad6
309317citric acid 66.8 MG/ML / potassium citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCD2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad6
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG per 5 ML Oral SolutionSY2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad6
309317Citric Acid 66.8 MG/ML / K+ citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSY2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad6
309317Citric Acid 66.8 MG/ML / Pot citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSY2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad6
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG in 5 mL Oral SolutionPSNd9e6b333-852b-4ddc-a3b7-32994201318e1
309317citric acid 66.8 MG/ML / potassium citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSCDd9e6b333-852b-4ddc-a3b7-32994201318e1
309317citric acid 334 MG / potassium citrate 550 MG / sodium citrate 500 MG per 5 ML Oral SolutionSYd9e6b333-852b-4ddc-a3b7-32994201318e1
309317Citric Acid 66.8 MG/ML / K+ citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSYd9e6b333-852b-4ddc-a3b7-32994201318e1
309317Citric Acid 66.8 MG/ML / Pot citrate 110 MG/ML / sodium citrate 100 MG/ML Oral SolutionSYd9e6b333-852b-4ddc-a3b7-32994201318e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0677-1600121067716473 mL in 1 BOTTLE (0121-0677-16) 473 ml2005-05-250000-00-00NoNoCurrent