Loratadine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 079825711

Effective Date

May 5, 2025

Labeling Type

HUMAN OTC DRUG LABEL

Active Ingredients

Loratadine(10 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70010-162

Application Number

ANDA210722

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 5, 2025

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Code: 7AJO3BO7QNClass: ACTIBQuantity: 10 mg in 1 1