Clarinex
Approved
Approval ID
4b546121-ef6b-458c-ae0c-ce5bba3dc9a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desloratidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4624
Application NumberNDA021297
Product Classification
M
Marketing Category
C73594
G
Generic Name
desloratidine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2010
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
DESLORATADINEActive
Quantity: 5 mg in 1 1
Code: FVF865388R
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT