Renacidin

Basic Information

Product Name

Renacidin

FDA Product Code

0327-0012

Regulatory Information

NDC Product Code

0327-0012

Application Number

NDA019481

Marketing Category

C73594

Effective Date

January 23, 2018

Territorial Authority

USA

FDA Title

Renacidin (Citric Acid, Glucono Delta-Lactone, and Magnesium Carbonate) Irrigation Solution

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS CITRIC ACID

Quantity: 6.602 g in 100 mL

Code: XF417D3PSL

Class Code: ACTIB

BENZOIC ACID

Code: 8SKN0B0MIM

Class Code: IACT

GLUCONOLACTONE

Quantity: 0.198 g in 100 mL

Code: WQ29KQ9POT

Class Code: ACTIB

MAGNESIUM CARBONATE

Quantity: 3.268 g in 100 mL

Code: 0E53J927NA

Class Code: ACTIB

Active Moieties

CARBONATE ION

Code: 7UJQ5OPE7D

GLUCONOLACTONE

Code: WQ29KQ9POT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Basic Information

Regulatory Information

Company Information

Active Ingredients

BENZOIC ACID

Active Moieties

CARBONATE ION

GLUCONOLACTONE

ANHYDROUS CITRIC ACID