loratadine allergy relief

Generic: loratadine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

loratadine 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-728
Product ID 55289-728_419b4a80-08b9-7408-e063-6294a90ac094
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076134
Listing Expiration 2026-12-31
Marketing Start 2017-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55289728
Hyphenated Format 55289-728

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 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
  • 10 TABLET in 1 BOTTLE, PLASTIC (55289-728-10)
  • 15 TABLET in 1 BOTTLE, PLASTIC (55289-728-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (55289-728-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (55289-728-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (55289-728-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (55289-728-90)
source: ndc

Packages (6)

55289-728-10 10 TABLET in 1 BOTTLE, PLASTIC (55289-728-10) 55289-728-15 15 TABLET in 1 BOTTLE, PLASTIC (55289-728-15) 55289-728-20 20 TABLET in 1 BOTTLE, PLASTIC (55289-728-20) 55289-728-30 30 TABLET in 1 BOTTLE, PLASTIC (55289-728-30) 55289-728-60 60 TABLET in 1 BOTTLE, PLASTIC (55289-728-60) 55289-728-90 90 TABLET in 1 BOTTLE, PLASTIC (55289-728-90)

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": "419b4a80-08b9-7408-e063-6294a90ac094", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["7127b39d-3686-4249-b720-43c02b4c4654"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (55289-728-10)", "package_ndc": "55289-728-10", "marketing_start_date": "20200930"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (55289-728-15)", "package_ndc": "55289-728-15", "marketing_start_date": "20210327"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (55289-728-20)", "package_ndc": "55289-728-20", "marketing_start_date": "20210327"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (55289-728-30)", "package_ndc": "55289-728-30", "marketing_start_date": "20180406"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (55289-728-60)", "package_ndc": "55289-728-60", "marketing_start_date": "20230118"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (55289-728-90)", "package_ndc": "55289-728-90", "marketing_start_date": "20180406"}], "brand_name": "Loratadine Allergy Relief", "product_id": "55289-728_419b4a80-08b9-7408-e063-6294a90ac094", "dosage_form": "TABLET", "product_ndc": "55289-728", "generic_name": "Loratadine", "labeler_name": "PD-Rx 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": "20171101", "listing_expiration_date": "20261231"}