Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Xttrium Laboratories, Inc.
007470579
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Xttrium Laboratories, Inc.`
Xttrium Laboratories, Inc.
Xttrium Laboratories, Inc.
007470579
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorhexidine Gluconate
Product Details
NDC Product Code
0116-0101Application Number
ANDA077789Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 23, 2020GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PEG-40 SORBITAN DIISOSTEARATEInactive
Code: JL4CCU7I1GClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ChlorhexidineActive
Code: MOR84MUD8EClass: ACTIBQuantity: 0.12 mg in 1 mL
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT