loratadine antihistamine

Generic: loratadine

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine antihistamine
Generic Name loratadine
Labeler padagis israel pharmaceuticals ltd
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-650
Product ID 45802-650_497be46d-b620-41ae-bac0-95ef0bd94fe4
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 45802650
Hyphenated Format 45802-650

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 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
  • 1 BOTTLE in 1 CARTON (45802-650-65) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (45802-650-75) / 90 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (45802-650-78) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (45802-650-87) / 300 TABLET in 1 BOTTLE
source: ndc

Packages (4)

45802-650-65 1 BOTTLE in 1 CARTON (45802-650-65) / 30 TABLET in 1 BOTTLE 45802-650-75 1 BOTTLE in 1 CARTON (45802-650-75) / 90 TABLET in 1 BOTTLE 45802-650-78 1 BOTTLE in 1 CARTON (45802-650-78) / 100 TABLET in 1 BOTTLE 45802-650-87 1 BOTTLE in 1 CARTON (45802-650-87) / 300 TABLET in 1 BOTTLE

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": "497be46d-b620-41ae-bac0-95ef0bd94fe4", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["c72d8a30-520e-4d25-8f02-0c891e070a1a"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-650-65)  / 30 TABLET in 1 BOTTLE", "package_ndc": "45802-650-65", "marketing_start_date": "20081015"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-650-75)  / 90 TABLET in 1 BOTTLE", "package_ndc": "45802-650-75", "marketing_end_date": "20261231", "marketing_start_date": "20230915"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-650-78)  / 100 TABLET in 1 BOTTLE", "package_ndc": "45802-650-78", "marketing_start_date": "20091007"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (45802-650-87)  / 300 TABLET in 1 BOTTLE", "package_ndc": "45802-650-87", "marketing_start_date": "20081028"}], "brand_name": "Loratadine antihistamine", "product_id": "45802-650_497be46d-b620-41ae-bac0-95ef0bd94fe4", "dosage_form": "TABLET", "product_ndc": "45802-650", "generic_name": "Loratadine", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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"}