Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Allegra--D 24 Hour
Product Details
NDC Product Code
54868-5419Application Number
NDA021704Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 25, 2012FexofenadineActive
Code: 2S068B75ZUClass: ACTIBQuantity: 180 mg in 1 1
PseudoephedrineActive
Code: 6V9V2RYJ8NClass: ACTIBQuantity: 240 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
COPOVIDONEInactive
Code: D9C330MD8BClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0AClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
ACETONEInactive
Code: 1364PS73AFClass: IACT