loratadine

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8880
Product ID 0378-8880_1392dd15-842c-4689-87ba-caafc0503bca
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076154
Listing Expiration 2026-12-31
Marketing Start 2011-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03788880
Hyphenated Format 0378-8880

Supplemental Identifiers

RxCUI
311372
UPC
0303788880100
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 ANDA076154 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10)
source: ndc

Packages (1)

0378-8880-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10)

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": "1392dd15-842c-4689-87ba-caafc0503bca", "openfda": {"upc": ["0303788880100"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["3b307aea-5a68-4c82-959a-cda4ffbd0a4a"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10)", "package_ndc": "0378-8880-10", "marketing_start_date": "20110601"}], "brand_name": "Loratadine", "product_id": "0378-8880_1392dd15-842c-4689-87ba-caafc0503bca", "dosage_form": "TABLET", "product_ndc": "0378-8880", "generic_name": "loratadine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076154", "marketing_category": "ANDA", "marketing_start_date": "20110601", "listing_expiration_date": "20261231"}