loratadine 10mg

Generic: loratadine 10mg

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine 10mg
Generic Name loratadine 10mg
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-475
Product ID 69168-475_1307fce8-d753-4df5-90f0-a902befdfe35
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211718
Listing Expiration 2026-12-31
Marketing Start 2025-03-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69168475
Hyphenated Format 69168-475

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 10mg (source: ndc)
Generic Name loratadine 10mg (source: ndc)
Application Number ANDA211718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 150 TABLET in 1 BOTTLE (69168-475-02)
  • 500 TABLET in 1 BOTTLE (69168-475-05)
  • 1 BLISTER PACK in 1 CARTON (69168-475-08) / 5 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (69168-475-09) / 10 TABLET in 1 BLISTER PACK
  • 300 TABLET in 1 BOTTLE (69168-475-17)
  • 1 BOTTLE in 1 CARTON (69168-475-30) / 30 TABLET in 1 BOTTLE
  • 60 TABLET in 1 BOTTLE (69168-475-60)
  • 365 TABLET in 1 BOTTLE (69168-475-99)
source: ndc

Packages (8)

69168-475-02 150 TABLET in 1 BOTTLE (69168-475-02) 69168-475-05 500 TABLET in 1 BOTTLE (69168-475-05) 69168-475-08 1 BLISTER PACK in 1 CARTON (69168-475-08) / 5 TABLET in 1 BLISTER PACK 69168-475-09 1 BLISTER PACK in 1 CARTON (69168-475-09) / 10 TABLET in 1 BLISTER PACK 69168-475-17 300 TABLET in 1 BOTTLE (69168-475-17) 69168-475-30 1 BOTTLE in 1 CARTON (69168-475-30) / 30 TABLET in 1 BOTTLE 69168-475-60 60 TABLET in 1 BOTTLE (69168-475-60) 69168-475-99 365 TABLET in 1 BOTTLE (69168-475-99)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Allergy Relief, Loratadine 10mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1307fce8-d753-4df5-90f0-a902befdfe35", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["f0db3a13-43e6-4243-9a3a-7808ddd005e1"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 TABLET in 1 BOTTLE (69168-475-02)", "package_ndc": "69168-475-02", "marketing_start_date": "20250318"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69168-475-05)", "package_ndc": "69168-475-05", "marketing_start_date": "20251111"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69168-475-08)  / 5 TABLET in 1 BLISTER PACK", "package_ndc": "69168-475-08", "marketing_start_date": "20250930"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69168-475-09)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "69168-475-09", "marketing_start_date": "20250930"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE (69168-475-17)", "package_ndc": "69168-475-17", "marketing_start_date": "20250930"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-475-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "69168-475-30", "marketing_start_date": "20250930"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (69168-475-60)", "package_ndc": "69168-475-60", "marketing_start_date": "20250930"}, {"sample": false, "description": "365 TABLET in 1 BOTTLE (69168-475-99)", "package_ndc": "69168-475-99", "marketing_start_date": "20250930"}], "brand_name": "Loratadine 10mg", "product_id": "69168-475_1307fce8-d753-4df5-90f0-a902befdfe35", "dosage_form": "TABLET", "product_ndc": "69168-475", "generic_name": "Loratadine 10mg", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine 10mg", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA211718", "marketing_category": "ANDA", "marketing_start_date": "20250318", "listing_expiration_date": "20261231"}