MedPath

Tricitrates

Tricitrates Oral Solution, USP Rx ONLY

Approved
Approval ID

2a80ea6b-6334-4c33-a35e-a5cb2939fbcb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2023

Manufacturers
FDA

Chartwell RX, LLC

DUNS: 079394054

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tricitrates

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62135-438
Product Classification
G
Generic Name
Tricitrates
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification

INGREDIENTS (8)

SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 550 mg in 5 mL
Code: EE90ONI6FF
Classification: ACTIB
SODIUM CITRATEActive
Quantity: 500 mg in 5 mL
Code: 1Q73Q2JULR
Classification: ACTIB
CITRIC ACID MONOHYDRATEActive
Quantity: 334 mg in 5 mL
Code: 2968PHW8QP
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Tricitrates - FDA Drug Approval Details