FDA Product

Loratadine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Loratadine

FDA Product Code

70010-162

Regulatory Information

NDC Product Code

70010-162

Application Number

ANDA210722

Marketing Category

C73584

Effective Date

May 5, 2025

Territorial Authority

USA

FDA Title

Loratadine Tablets, 10 mg

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

5

Company Information

ManufacturerGranules Pharmaceuticals Inc.

DUNS Number

079825711

Active Ingredients

Quantity: 10 mg in 1 1

Code: 7AJO3BO7QN

Class Code: ACTIB

Inactive Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

LORATADINE

Code: 7AJO3BO7QN

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