dye-free childrens loratadine

Generic: loratadine

Labeler: up & up
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

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 11673-115
Product ID 11673-115_1bf17f48-004c-0f27-e063-6294a90a20c4
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 11673115
Hyphenated Format 11673-115

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 (11673-115-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (1)

11673-115-30 3 BLISTER PACK in 1 CARTON (11673-115-30) / 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": "1bf17f48-004c-0f27-e063-6294a90a20c4", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["665078"], "spl_set_id": ["85ea5c40-d02f-4c91-8eb2-4b16877e1eab"], "manufacturer_name": ["UP & UP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (11673-115-30)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11673-115-30", "marketing_start_date": "20201117"}], "brand_name": "Dye-Free Childrens Loratadine", "product_id": "11673-115_1bf17f48-004c-0f27-e063-6294a90a20c4", "dosage_form": "TABLET, CHEWABLE", "product_ndc": "11673-115", "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"}