Renacidin
Renacidin (Citric Acid, Glucono Delta-Lactone, and Magnesium Carbonate) Irrigation Solution
Approved
Approval ID
13a9bbba-db21-4cba-991c-5d8afaf2ed74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2019
Manufacturers
FDA
United-Guardian, Inc.
DUNS: 050594555
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
citric acid, gluconolactone and magnesium carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0327-0012
Application NumberNDA019481
Product Classification
M
Marketing Category
C73594
G
Generic Name
citric acid, gluconolactone and magnesium carbonate
Product Specifications
Route of AdministrationIRRIGATION
Effective DateJanuary 23, 2018
FDA Product Classification
INGREDIENTS (4)
ANHYDROUS CITRIC ACIDActive
Quantity: 6.602 g in 100 mL
Code: XF417D3PSL
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
GLUCONOLACTONEActive
Quantity: 0.198 g in 100 mL
Code: WQ29KQ9POT
Classification: ACTIB
MAGNESIUM CARBONATEActive
Quantity: 3.268 g in 100 mL
Code: 0E53J927NA
Classification: ACTIB