dye-free childrens loratadine (11673-111)

Drug Facts

Product Profile

Brand Name dye-free childrens loratadine

Generic Name loratadine

Labeler up & up

Dosage Form TABLET, CHEWABLE

Routes

ORAL

Active Ingredients

loratadine 5 mg/1

Manufacturer

UP & UP

Identifiers & Regulatory

Product NDC 11673-111

Product ID 11673-111_b9e6809c-e0ce-4205-98c5-665af1716503

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210088

Listing Expiration 2026-12-31

Marketing Start 2020-11-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11673111

Hyphenated Format 11673-111

Supplemental Identifiers

RxCUI

665078

UNII

7AJO3BO7QN

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dye-free childrens loratadine (source: ndc)

Generic Name loratadine (source: ndc)

Application Number ANDA210088 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1

source: ndc

Packaging

3 BLISTER PACK in 1 CARTON (11673-111-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

source: ndc

Packages (1)

11673-111-30 3 BLISTER PACK in 1 CARTON (11673-111-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

loratadine (5 mg/1)

Linked Drug Pages (1)

DYE-FREE CHILDRENS LORATADINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "b9e6809c-e0ce-4205-98c5-665af1716503", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["665078"], "spl_set_id": ["9660f7e6-3a29-4a6d-ba57-92088f624aa4"], "manufacturer_name": ["UP & UP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (11673-111-30)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11673-111-30", "marketing_start_date": "20201117"}], "brand_name": "DYE-FREE CHILDRENS LORATADINE", "product_id": "11673-111_b9e6809c-e0ce-4205-98c5-665af1716503", "dosage_form": "TABLET, CHEWABLE", "product_ndc": "11673-111", "generic_name": "LORATADINE", "labeler_name": "UP & UP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DYE-FREE CHILDRENS LORATADINE", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA210088", "marketing_category": "ANDA", "marketing_start_date": "20201117", "listing_expiration_date": "20261231"}