loratadine

Generic: loratadine

Labeler: tenshi kaizen pvt ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler tenshi kaizen pvt ltd
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 5 mg/1

Manufacturer
Tenshi Kaizen Pvt Ltd

Identifiers & Regulatory

Product NDC 72983-500
Product ID 72983-500_0df0dfde-1f52-4769-e063-6394a90a2f92
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212795
Listing Expiration 2026-12-31
Marketing Start 2021-05-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72983500
Hyphenated Format 72983-500

Supplemental Identifiers

RxCUI
672558
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 ANDA212795 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (72983-500-01) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

72983-500-01 1 BLISTER PACK in 1 CARTON (72983-500-01) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

loratadine (5 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": "0df0dfde-1f52-4769-e063-6394a90a2f92", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["672558"], "spl_set_id": ["c20b91e0-ef92-6f2f-e053-2a95a90a2a36"], "manufacturer_name": ["Tenshi Kaizen Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (72983-500-01)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "72983-500-01", "marketing_start_date": "20210519"}], "brand_name": "Loratadine", "product_id": "72983-500_0df0dfde-1f52-4769-e063-6394a90a2f92", "dosage_form": "TABLET", "product_ndc": "72983-500", "generic_name": "Loratadine", "labeler_name": "Tenshi Kaizen Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA212795", "marketing_category": "ANDA", "marketing_start_date": "20210519", "listing_expiration_date": "20261231"}