loratadine

Generic: loratadine oral

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

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine oral
Labeler aurohealth llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loratadine 5 mg/5mL

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-423
Product ID 58602-423_78515214-94d8-4977-aff5-8b9beb60042e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208931
Listing Expiration 2026-12-31
Marketing Start 2018-06-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602423
Hyphenated Format 58602-423

Supplemental Identifiers

RxCUI
692783
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 oral (source: ndc)
Application Number ANDA208931 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-423-11) / 60 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-423-24) / 120 mL in 1 BOTTLE
source: ndc

Packages (2)

58602-423-11 1 BOTTLE in 1 CARTON (58602-423-11) / 60 mL in 1 BOTTLE 58602-423-24 1 BOTTLE in 1 CARTON (58602-423-24) / 120 mL in 1 BOTTLE

Ingredients (1)

loratadine (5 mg/5mL)

Linked Drug Pages (1)

Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "78515214-94d8-4977-aff5-8b9beb60042e", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["692783"], "spl_set_id": ["0b86a9fe-db7e-470a-a8fa-d7d4373116ba"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-423-11)  / 60 mL in 1 BOTTLE", "package_ndc": "58602-423-11", "marketing_start_date": "20180629"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-423-24)  / 120 mL in 1 BOTTLE", "package_ndc": "58602-423-24", "marketing_start_date": "20180629"}], "brand_name": "Loratadine", "product_id": "58602-423_78515214-94d8-4977-aff5-8b9beb60042e", "dosage_form": "SOLUTION", "product_ndc": "58602-423", "generic_name": "Loratadine Oral", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/5mL"}], "application_number": "ANDA208931", "marketing_category": "ANDA", "marketing_start_date": "20180629", "listing_expiration_date": "20261231"}