loratadine antihistamine

Generic: loratadine

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine antihistamine
Generic Name loratadine
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8217
Product ID 0615-8217_795e1026-4893-4066-891a-3dec5223db50
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2026-12-31
Marketing Start 2025-11-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158217
Hyphenated Format 0615-8217

Supplemental Identifiers

RxCUI
311372
UNII
7AJO3BO7QN

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 antihistamine (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8217-30) / 5 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BLISTER PACK (0615-8217-39)
source: ndc

Packages (2)

0615-8217-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8217-30) / 5 TABLET in 1 BLISTER PACK 0615-8217-39 30 TABLET in 1 BLISTER PACK (0615-8217-39)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine antihistamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "795e1026-4893-4066-891a-3dec5223db50", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["f3d05276-21bd-419d-8dba-07ce278d3375"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8217-30)  / 5 TABLET in 1 BLISTER PACK", "package_ndc": "0615-8217-30", "marketing_start_date": "20251219"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8217-39)", "package_ndc": "0615-8217-39", "marketing_start_date": "20251120"}], "brand_name": "Loratadine antihistamine", "product_id": "0615-8217_795e1026-4893-4066-891a-3dec5223db50", "dosage_form": "TABLET", "product_ndc": "0615-8217", "generic_name": "Loratadine", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "brand_name_suffix": "antihistamine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076301", "marketing_category": "ANDA", "marketing_start_date": "20251120", "listing_expiration_date": "20261231"}