Desloratadine
These highlights do not include all the information needed to use DESLORATADINE safely and effectively. See full prescribing information for DESLORATADINE TABLETS. DESLORATADINE tablets for oral use Initial U.S. Approval: 2001
Approved
Approval ID
58ba2dc8-10c2-4532-92e2-40ec2fee3378
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 6, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-523
Application NumberANDA078359
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desloratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 8, 2019
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
DESLORATADINEActive
Quantity: 5 mg in 1 1
Code: FVF865388R
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT