Desloratadine
Desloratadine Tablets These highlights do not include all the information needed to use Desloratadine safely and effectively. See full prescribing information for Desloratadine. Desloratadine (Desloratadine) TABLET for ORAL use. Initial U.S. Approval: 2001
Approved
Approval ID
dbb8e695-f00b-4c67-bd49-09a1ae5bb669
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Belcher Pharmaceuticals,LLC
DUNS: 965082543
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Desloratadine
PRODUCT DETAILS
NDC Product Code62250-619
Application NumberANDA078355
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 5, 2023
Generic NameDesloratadine
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DESLORATADINEActive
Quantity: 5 mg in 1 1
Code: FVF865388R
Classification: ACTIB