loratadine

Generic: loratadine oral

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

Drug Facts

Product Profile

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

loratadine 5 mg/5mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-449
Product ID 68001-449_352cf9e6-9f6c-b81e-e063-6394a90a397f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208931
Listing Expiration 2026-12-31
Marketing Start 2020-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001449
Hyphenated Format 68001-449

Supplemental Identifiers

RxCUI
692783
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 oral (source: ndc)
Application Number ANDA208931 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68001-449-98) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

68001-449-98 1 BOTTLE in 1 CARTON (68001-449-98) / 120 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "352cf9e6-9f6c-b81e-e063-6394a90a397f", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["ab820f80-b5fc-7896-e053-2995a90a4b1c"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68001-449-98)  / 120 mL in 1 BOTTLE", "package_ndc": "68001-449-98", "marketing_start_date": "20200731"}], "brand_name": "Loratadine", "product_id": "68001-449_352cf9e6-9f6c-b81e-e063-6394a90a397f", "dosage_form": "SOLUTION", "product_ndc": "68001-449", "generic_name": "Loratadine Oral", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA208931", "marketing_category": "ANDA", "marketing_start_date": "20200731", "listing_expiration_date": "20261231"}