loratadine

Generic: loratadine

Labeler: bluepoint laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-438
Product ID 68001-438_e1e021de-1501-2fe3-e053-2a95a90a7be9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208314
Listing Expiration 2026-12-31
Marketing Start 2020-08-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001438
Hyphenated Format 68001-438

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 (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA208314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68001-438-00) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68001-438-04) / 30 TABLET in 1 BOTTLE
  • 10 BLISTER PACK in 1 CARTON (68001-438-96) / 10 TABLET in 1 BLISTER PACK (68001-438-16)
  • 1 BOTTLE in 1 CARTON (68001-438-97) / 300 TABLET in 1 BOTTLE
source: ndc

Packages (4)

68001-438-00 1 BOTTLE in 1 CARTON (68001-438-00) / 100 TABLET in 1 BOTTLE 68001-438-04 1 BOTTLE in 1 CARTON (68001-438-04) / 30 TABLET in 1 BOTTLE 68001-438-96 10 BLISTER PACK in 1 CARTON (68001-438-96) / 10 TABLET in 1 BLISTER PACK (68001-438-16) 68001-438-97 1 BOTTLE in 1 CARTON (68001-438-97) / 300 TABLET in 1 BOTTLE

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": "e1e021de-1501-2fe3-e053-2a95a90a7be9", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["adc506ed-7a7a-facc-e053-2a95a90ae147"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68001-438-00)  / 100 TABLET in 1 BOTTLE", "package_ndc": "68001-438-00", "marketing_start_date": "20200826"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68001-438-04)  / 30 TABLET in 1 BOTTLE", "package_ndc": "68001-438-04", "marketing_start_date": "20200826"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68001-438-96)  / 10 TABLET in 1 BLISTER PACK (68001-438-16)", "package_ndc": "68001-438-96", "marketing_start_date": "20200826"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68001-438-97)  / 300 TABLET in 1 BOTTLE", "package_ndc": "68001-438-97", "marketing_start_date": "20200826"}], "brand_name": "Loratadine", "product_id": "68001-438_e1e021de-1501-2fe3-e053-2a95a90a7be9", "dosage_form": "TABLET", "product_ndc": "68001-438", "generic_name": "Loratadine", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA208314", "marketing_category": "ANDA", "marketing_start_date": "20200826", "listing_expiration_date": "20261231"}