Allergy Relief
Drug Facts
Approved
Approval ID
706a59fa-3d15-4e6e-a38e-ad3f2ef46600
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
WinCo Foods, LLC
DUNS: 056098817
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loratadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67091-350
Application NumberANDA075209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
LORATADINEActive
Quantity: 10 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB