FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE
Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets
Approved
Approval ID
e4020ca3-82d0-4668-b4bc-92e4a53c1f4e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-820
Application NumberNDA020786
Product Classification
M
Marketing Category
C73594
G
Generic Name
FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2009
FDA Product Classification
INGREDIENTS (10)
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 120 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT