Clarinex
These highlights do not include all the information needed to use CLARINEX safely and effectively. See full prescribing information for CLARINEX. CLARINEX (desloratadine) Tablets, RediTabs, and Oral Solution for oral useInitial U.S. Approval: 2001
Approved
Approval ID
a7b5d043-da63-499c-b8bd-adf9295a6975
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Desloratadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-0765
Application NumberNDA021165
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desloratadine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2021
FDA Product Classification
INGREDIENTS (13)
DESLORATADINEActive
Quantity: 5 mg in 1 1
Code: FVF865388R
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT