loratadine 10mg

Generic: loratadine 10mg

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine 10mg
Generic Name loratadine 10mg
Labeler marksans pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-092
Product ID 25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA219223
Listing Expiration 2026-12-31
Marketing Start 2024-11-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25000092
Hyphenated Format 25000-092

Supplemental Identifiers

RxCUI
311372
UPC
0325000092795 0325000092801 0325000092818 0325000092030
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 10mg (source: ndc)
Generic Name loratadine 10mg (source: ndc)
Application Number ANDA219223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-092-03) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (25000-092-79) / 150 TABLET in 1 BOTTLE
  • 365 TABLET in 1 BOTTLE (25000-092-80)
  • 2 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

25000-092-03 1 BOTTLE in 1 CARTON (25000-092-03) / 30 TABLET in 1 BOTTLE 25000-092-79 1 BOTTLE in 1 CARTON (25000-092-79) / 150 TABLET in 1 BOTTLE 25000-092-80 365 TABLET in 1 BOTTLE (25000-092-80) 25000-092-81 2 BLISTER PACK in 1 CARTON (25000-092-81) / 7 TABLET in 1 BLISTER PACK

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine 10mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aa667b5f-a4ac-4129-bae9-f9c1de776629", "openfda": {"upc": ["0325000092795", "0325000092801", "0325000092818", "0325000092030"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["3360d02d-612d-4cc5-acc9-2cc93713c387"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-092-03)  / 30 TABLET in 1 BOTTLE", "package_ndc": "25000-092-03", "marketing_start_date": "20241121"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-092-79)  / 150 TABLET in 1 BOTTLE", "package_ndc": "25000-092-79", "marketing_start_date": "20241121"}, {"sample": false, "description": "365 TABLET in 1 BOTTLE (25000-092-80)", "package_ndc": "25000-092-80", "marketing_start_date": "20241121"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (25000-092-81)  / 7 TABLET in 1 BLISTER PACK", "package_ndc": "25000-092-81", "marketing_start_date": "20241121"}], "brand_name": "Loratadine 10mg", "product_id": "25000-092_aa667b5f-a4ac-4129-bae9-f9c1de776629", "dosage_form": "TABLET", "product_ndc": "25000-092", "generic_name": "Loratadine 10mg", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine 10mg", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA219223", "marketing_category": "ANDA", "marketing_start_date": "20241121", "listing_expiration_date": "20261231"}