loratadine

Generic: loratadine

Labeler: spirit pharmaceuticals llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler spirit pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Spirit Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 68210-4110
Product ID 68210-4110_292df514-5dba-2a76-e063-6394a90acee6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210722
Listing Expiration 2026-12-31
Marketing Start 2020-09-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 682104110
Hyphenated Format 68210-4110

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 ANDA210722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 365 TABLET in 1 BOTTLE (68210-4110-1)
source: ndc

Packages (1)

68210-4110-1 365 TABLET in 1 BOTTLE (68210-4110-1)

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": "292df514-5dba-2a76-e063-6394a90acee6", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["af0cdab2-27a4-5f30-e053-2a95a90a5e71"], "manufacturer_name": ["Spirit Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "365 TABLET in 1 BOTTLE (68210-4110-1)", "package_ndc": "68210-4110-1", "marketing_start_date": "20200911"}], "brand_name": "Loratadine", "product_id": "68210-4110_292df514-5dba-2a76-e063-6394a90acee6", "dosage_form": "TABLET", "product_ndc": "68210-4110", "generic_name": "Loratadine", "labeler_name": "Spirit Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA210722", "marketing_category": "ANDA", "marketing_start_date": "20200911", "listing_expiration_date": "20261231"}