loratadine allergy relief

Generic: loratadine

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine allergy relief
Generic Name loratadine
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-763
Product ID 10135-763_43e1e645-7da5-86de-e063-6394a90a7f3a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076134
Listing Expiration 2026-12-31
Marketing Start 2022-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135763
Hyphenated Format 10135-763

Supplemental Identifiers

RxCUI
311372
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 allergy relief (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 300 TABLET in 1 BOTTLE (10135-763-03)
  • 30 TABLET in 1 BOTTLE (10135-763-30)
  • 90 TABLET in 1 BOTTLE (10135-763-90)
source: ndc

Packages (3)

10135-763-03 300 TABLET in 1 BOTTLE (10135-763-03) 10135-763-30 30 TABLET in 1 BOTTLE (10135-763-30) 10135-763-90 90 TABLET in 1 BOTTLE (10135-763-90)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine Allergy Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43e1e645-7da5-86de-e063-6394a90a7f3a", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["ec08a6ee-3d71-0fa9-e053-2995a90a9cb1"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "300 TABLET in 1 BOTTLE (10135-763-03)", "package_ndc": "10135-763-03", "marketing_start_date": "20221001"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (10135-763-30)", "package_ndc": "10135-763-30", "marketing_start_date": "20221001"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (10135-763-90)", "package_ndc": "10135-763-90", "marketing_start_date": "20221001"}], "brand_name": "Loratadine Allergy Relief", "product_id": "10135-763_43e1e645-7da5-86de-e063-6394a90a7f3a", "dosage_form": "TABLET", "product_ndc": "10135-763", "generic_name": "Loratadine", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine Allergy Relief", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076134", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20261231"}