loratadine antihistamine

Generic: loratadine

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine antihistamine
Generic Name loratadine
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-601
Product ID 63187-601_d36424c7-b438-4c23-884d-d4bfdac81fcf
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2026-12-31
Marketing Start 2008-10-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187601
Hyphenated Format 63187-601

Supplemental Identifiers

RxCUI
311372
UPC
0363187601607
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
  • 10 TABLET in 1 BOTTLE (63187-601-10)
  • 14 TABLET in 1 BOTTLE (63187-601-14)
  • 30 TABLET in 1 BOTTLE (63187-601-30)
  • 60 TABLET in 1 BOTTLE (63187-601-60)
  • 90 TABLET in 1 BOTTLE (63187-601-90)
source: ndc

Packages (5)

63187-601-10 10 TABLET in 1 BOTTLE (63187-601-10) 63187-601-14 14 TABLET in 1 BOTTLE (63187-601-14) 63187-601-30 30 TABLET in 1 BOTTLE (63187-601-30) 63187-601-60 60 TABLET in 1 BOTTLE (63187-601-60) 63187-601-90 90 TABLET in 1 BOTTLE (63187-601-90)

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": "d36424c7-b438-4c23-884d-d4bfdac81fcf", "openfda": {"upc": ["0363187601607"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["e9b87f79-ebed-4677-8e50-00cb4282ee56"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (63187-601-10)", "package_ndc": "63187-601-10", "marketing_start_date": "20170801"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (63187-601-14)", "package_ndc": "63187-601-14", "marketing_start_date": "20170801"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-601-30)", "package_ndc": "63187-601-30", "marketing_start_date": "20170801"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-601-60)", "package_ndc": "63187-601-60", "marketing_start_date": "20170801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-601-90)", "package_ndc": "63187-601-90", "marketing_start_date": "20170801"}], "brand_name": "Loratadine antihistamine", "product_id": "63187-601_d36424c7-b438-4c23-884d-d4bfdac81fcf", "dosage_form": "TABLET", "product_ndc": "63187-601", "generic_name": "Loratadine", "labeler_name": "Proficient Rx LP", "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": "20081015", "listing_expiration_date": "20261231"}