loratadine

Generic: loratadine

Labeler: avpak
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-489
Product ID 50268-489_4847390c-c472-8f29-e063-6394a90ab43d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208314
Marketing Start 2019-05-28
Marketing End 2026-03-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268489
Hyphenated Format 50268-489

Supplemental Identifiers

RxCUI
311372
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 loratadine (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA208314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-489-15) / 1 TABLET in 1 BLISTER PACK (50268-489-11)
source: ndc

Packages (1)

50268-489-15 50 BLISTER PACK in 1 BOX (50268-489-15) / 1 TABLET in 1 BLISTER PACK (50268-489-11)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4847390c-c472-8f29-e063-6394a90ab43d", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["89f7abee-eab9-fe82-e053-2995a90a71eb"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-489-15)  / 1 TABLET in 1 BLISTER PACK (50268-489-11)", "package_ndc": "50268-489-15", "marketing_end_date": "20260331", "marketing_start_date": "20190528"}], "brand_name": "Loratadine", "product_id": "50268-489_4847390c-c472-8f29-e063-6394a90ab43d", "dosage_form": "TABLET", "product_ndc": "50268-489", "generic_name": "Loratadine", "labeler_name": "AvPAK", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA208314", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20190528"}