FDA Product

Sodium Citrate and Citric Acid

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Sodium Citrate and Citric Acid

FDA Product Code

62135-434

Regulatory Information

NDC Product Code

62135-434

Effective Date

October 5, 2023

FDA Title

Sodium Citrate and Citric Acid Oral Solution, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerChartwell RX, LLC

DUNS Number

079394054

Active Ingredients

CITRIC ACID MONOHYDRATE

Quantity: 334 mg in 5 mL

Code: 2968PHW8QP

Class Code: ACTIM

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

SORBITOL SOLUTION

Code: 8KW3E207O2

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

Quantity: 500 mg in 5 mL

Code: 1Q73Q2JULR

Class Code: ACTIB

Active Moieties

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy