loratadine

Generic: loratadine

Labeler: gobrands, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler gobrands, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Gobrands, Inc

Identifiers & Regulatory

Product NDC 82501-1580
Product ID 82501-1580_2c81c9aa-35e4-6008-e063-6294a90a9bc9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA214684
Listing Expiration 2026-12-31
Marketing Start 2022-05-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 825011580
Hyphenated Format 82501-1580

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 (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA214684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (82501-1580-3) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

82501-1580-3 1 BOTTLE in 1 CARTON (82501-1580-3) / 30 TABLET in 1 BOTTLE

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c81c9aa-35e4-6008-e063-6294a90a9bc9", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["1d182bd6-ad72-4352-b983-407a48c317f0"], "manufacturer_name": ["Gobrands, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (82501-1580-3)  / 30 TABLET in 1 BOTTLE", "package_ndc": "82501-1580-3", "marketing_start_date": "20220516"}], "brand_name": "Loratadine", "product_id": "82501-1580_2c81c9aa-35e4-6008-e063-6294a90a9bc9", "dosage_form": "TABLET", "product_ndc": "82501-1580", "generic_name": "Loratadine", "labeler_name": "Gobrands, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA214684", "marketing_category": "ANDA", "marketing_start_date": "20220516", "listing_expiration_date": "20261231"}