loratadine

Generic: loratadine

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0352
Product ID 80425-0352_2a9c2eb6-a6de-f647-e063-6294a90a93fe
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214684
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250352
Hyphenated Format 80425-0352

Supplemental Identifiers

RxCUI
311372
UNII
7AJO3BO7QN

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 ANDA214684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (80425-0352-1)
source: ndc

Packages (1)

80425-0352-1 30 TABLET in 1 BOTTLE (80425-0352-1)

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": "2a9c2eb6-a6de-f647-e063-6294a90a93fe", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["01cb43cf-57a9-f189-e063-6294a90afd88"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (80425-0352-1)", "package_ndc": "80425-0352-1", "marketing_start_date": "20230731"}], "brand_name": "Loratadine", "product_id": "80425-0352_2a9c2eb6-a6de-f647-e063-6294a90a93fe", "dosage_form": "TABLET", "product_ndc": "80425-0352", "generic_name": "loratadine", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA214684", "marketing_category": "ANDA", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}