loratadine odt

Generic: loratadine

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

loratadine 10 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-830
Product ID 58602-830_5c099ee7-0679-45af-ac3d-d8e77d12e809
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208477
Listing Expiration 2026-12-31
Marketing Start 2018-04-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602830
Hyphenated Format 58602-830

Supplemental Identifiers

RxCUI
311373
UPC
0358602830830
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
  • 1 BLISTER PACK in 1 CARTON (58602-830-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

58602-830-83 1 BLISTER PACK in 1 CARTON (58602-830-83) / 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": "5c099ee7-0679-45af-ac3d-d8e77d12e809", "openfda": {"upc": ["0358602830830"], "unii": ["7AJO3BO7QN"], "rxcui": ["311373"], "spl_set_id": ["1ba8e521-0b0f-419c-b7c3-fa9586f83f36"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-830-83)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "58602-830-83", "marketing_start_date": "20180411"}], "brand_name": "Loratadine ODT", "product_id": "58602-830_5c099ee7-0679-45af-ac3d-d8e77d12e809", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "product_ndc": "58602-830", "generic_name": "Loratadine", "labeler_name": "Aurohealth LLC", "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": "20180411", "listing_expiration_date": "20261231"}