loratadine odt

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name loratadine odt
Generic Name loratadine
Labeler rugby laboratories
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1367
Product ID 0536-1367_f59f3400-da77-4eb7-be02-842071d87fae
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208477
Listing Expiration 2026-12-31
Marketing Start 2022-10-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361367
Hyphenated Format 0536-1367

Supplemental Identifiers

RxCUI
311373
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 odt (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA208477 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0536-1367-07) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

0536-1367-07 3 BLISTER PACK in 1 CARTON (0536-1367-07) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine ODT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f59f3400-da77-4eb7-be02-842071d87fae", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311373"], "spl_set_id": ["f59f3400-da77-4eb7-be02-842071d87fae"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0536-1367-07)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "0536-1367-07", "marketing_start_date": "20221006"}], "brand_name": "Loratadine ODT", "product_id": "0536-1367_f59f3400-da77-4eb7-be02-842071d87fae", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "0536-1367", "generic_name": "Loratadine", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine ODT", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA208477", "marketing_category": "ANDA", "marketing_start_date": "20221006", "listing_expiration_date": "20261231"}