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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Tenshi Kaizen Pvt Ltd

Identifiers & Regulatory

Product NDC 72983-501
Product ID 72983-501_0df121d3-d784-620c-e063-6294a90acdab
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA213294
Listing Expiration 2026-12-31
Marketing Start 2021-05-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72983501
Hyphenated Format 72983-501

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 (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA213294 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (72983-501-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (72983-501-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (2)

72983-501-01 1 BLISTER PACK in 1 CARTON (72983-501-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 72983-501-03 3 BLISTER PACK in 1 CARTON (72983-501-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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": "0df121d3-d784-620c-e063-6294a90acdab", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311373"], "spl_set_id": ["c20b916d-7dd0-1a56-e053-2995a90a3c1b"], "manufacturer_name": ["Tenshi Kaizen Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (72983-501-01)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "72983-501-01", "marketing_start_date": "20210519"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (72983-501-03)  / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "72983-501-03", "marketing_start_date": "20210519"}], "brand_name": "LORATADINE", "product_id": "72983-501_0df121d3-d784-620c-e063-6294a90acdab", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "72983-501", "generic_name": "LORATADINE", "labeler_name": "Tenshi Kaizen Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LORATADINE", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA213294", "marketing_category": "ANDA", "marketing_start_date": "20210519", "listing_expiration_date": "20261231"}