Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bajaj Medical, LLC
078774921
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bajaj Medical, LLC
Bajaj Medical, LLC
Bajaj Medical, LLC
078774921
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorhexidine Gluconate, 0.12% Oral Rinse Solution
Product Details
NDC Product Code
61037-469Application Number
ANDA075561Marketing Category
ANDA (C73584)Route of Administration
DENTALEffective Date
January 2, 2024FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
ChlorhexidineActive
Code: MOR84MUD8EClass: ACTIBQuantity: 1.2 mg in 1 mL
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1GClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT