loratadine

Generic: loratadine

Labeler: preferred pharmaceuticals inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler preferred pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 68788-8616
Product ID 68788-8616_5123b650-8bfd-4281-a824-cbb185d84867
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214684
Listing Expiration 2026-12-31
Marketing Start 2024-03-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888616
Hyphenated Format 68788-8616

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
  • 100 TABLET in 1 BOTTLE (68788-8616-0)
  • 14 TABLET in 1 BOTTLE (68788-8616-1)
  • 30 TABLET in 1 BOTTLE (68788-8616-3)
  • 15 TABLET in 1 BOTTLE (68788-8616-5)
  • 10 TABLET in 1 BOTTLE (68788-8616-8)
  • 90 TABLET in 1 BOTTLE (68788-8616-9)
source: ndc

Packages (6)

68788-8616-0 100 TABLET in 1 BOTTLE (68788-8616-0) 68788-8616-1 14 TABLET in 1 BOTTLE (68788-8616-1) 68788-8616-3 30 TABLET in 1 BOTTLE (68788-8616-3) 68788-8616-5 15 TABLET in 1 BOTTLE (68788-8616-5) 68788-8616-8 10 TABLET in 1 BOTTLE (68788-8616-8) 68788-8616-9 90 TABLET in 1 BOTTLE (68788-8616-9)

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": "5123b650-8bfd-4281-a824-cbb185d84867", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["0a0d700d-bdba-4c90-a947-5d61d40ce4df"], "manufacturer_name": ["Preferred Pharmaceuticals Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8616-0)", "package_ndc": "68788-8616-0", "marketing_start_date": "20240326"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (68788-8616-1)", "package_ndc": "68788-8616-1", "marketing_start_date": "20240326"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8616-3)", "package_ndc": "68788-8616-3", "marketing_start_date": "20240326"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (68788-8616-5)", "package_ndc": "68788-8616-5", "marketing_start_date": "20240326"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (68788-8616-8)", "package_ndc": "68788-8616-8", "marketing_start_date": "20240521"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8616-9)", "package_ndc": "68788-8616-9", "marketing_start_date": "20240326"}], "brand_name": "Loratadine", "product_id": "68788-8616_5123b650-8bfd-4281-a824-cbb185d84867", "dosage_form": "TABLET", "product_ndc": "68788-8616", "generic_name": "loratadine", "labeler_name": "Preferred Pharmaceuticals Inc", "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": "20240326", "listing_expiration_date": "20261231"}