loratadine antihistamine

Generic: loratadine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine antihistamine
Generic Name loratadine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-259
Product ID 43353-259_15aaaeb4-fda5-f5e2-e063-6394a90a47ee
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2026-12-31
Marketing Start 2008-10-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353259
Hyphenated Format 43353-259

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 antihistamine (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 9000 TABLET in 1 BOTTLE (43353-259-09)
  • 3000 TABLET in 1 BOTTLE (43353-259-18)
  • 90 TABLET in 1 BOTTLE (43353-259-60)
source: ndc

Packages (3)

43353-259-09 9000 TABLET in 1 BOTTLE (43353-259-09) 43353-259-18 3000 TABLET in 1 BOTTLE (43353-259-18) 43353-259-60 90 TABLET in 1 BOTTLE (43353-259-60)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine antihistamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "15aaaeb4-fda5-f5e2-e063-6394a90a47ee", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["a2c92766-df4e-4414-9c42-e18bcf9db6b4"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET in 1 BOTTLE (43353-259-09)", "package_ndc": "43353-259-09", "marketing_start_date": "20220908"}, {"sample": false, "description": "3000 TABLET in 1 BOTTLE (43353-259-18)", "package_ndc": "43353-259-18", "marketing_start_date": "20221017"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43353-259-60)", "package_ndc": "43353-259-60", "marketing_start_date": "20161123"}], "brand_name": "Loratadine antihistamine", "product_id": "43353-259_15aaaeb4-fda5-f5e2-e063-6394a90a47ee", "dosage_form": "TABLET", "product_ndc": "43353-259", "generic_name": "Loratadine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "brand_name_suffix": "antihistamine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076301", "marketing_category": "ANDA", "marketing_start_date": "20081015", "listing_expiration_date": "20261231"}