Loratadine
Loratadine Tablets, 10 mg
Approved
Approval ID
d15add22-bc2d-9730-e053-2a95a90acd3f
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 5, 2025
Manufacturers
FDA
Granules Pharmaceuticals Inc.
DUNS: 079825711
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 Code70010-162
Application NumberANDA210722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loratadine
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2025
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LORATADINEActive
Quantity: 10 mg in 1 1
Code: 7AJO3BO7QN
Classification: ACTIB