loratadine

Generic: loratadine

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler advanced rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-711
Product ID 80513-711_2efad4c4-593e-fa4d-e063-6294a90a0ebc
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210722
Listing Expiration 2026-12-31
Marketing Start 2020-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513711
Hyphenated Format 80513-711

Supplemental Identifiers

RxCUI
311372
UPC
0380513001184
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 ANDA210722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (80513-711-01)
  • 300 TABLET in 1 BOTTLE (80513-711-03)
source: ndc

Packages (2)

80513-711-01 100 TABLET in 1 BOTTLE (80513-711-01) 80513-711-03 300 TABLET in 1 BOTTLE (80513-711-03)

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": "2efad4c4-593e-fa4d-e063-6294a90a0ebc", "openfda": {"upc": ["0380513001184"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (80513-711-01)", "package_ndc": "80513-711-01", "marketing_start_date": "20240101"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (80513-711-03)", "package_ndc": "80513-711-03", "marketing_start_date": "20240807"}], "brand_name": "Loratadine", "product_id": "80513-711_2efad4c4-593e-fa4d-e063-6294a90a0ebc", "dosage_form": "TABLET", "product_ndc": "80513-711", "generic_name": "Loratadine", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA210722", "marketing_category": "ANDA", "marketing_start_date": "20200101", "listing_expiration_date": "20261231"}