ALLEGRA-D 24 HOUR
Approved
Approval ID
741e8b74-2bb5-4153-9727-92ad91e9e9a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2009
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-852
Application NumberNDA021704
Product Classification
M
Marketing Category
C73594
G
Generic Name
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2009
FDA Product Classification
INGREDIENTS (21)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 240 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 180 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ACETONEInactive
Code: 1364PS73AF
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT