loratadine

Generic: loratadine

Labeler: mclane company, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler mclane company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
McLane Company, Inc.

Identifiers & Regulatory

Product NDC 57243-200
Product ID 57243-200_9874d1db-f339-49f9-8225-ca61c05f1d64
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208314
Listing Expiration 2026-12-31
Marketing Start 2018-04-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57243200
Hyphenated Format 57243-200

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 ANDA208314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (57243-200-69) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

57243-200-69 1 BLISTER PACK in 1 CARTON (57243-200-69) / 10 TABLET in 1 BLISTER PACK

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": "9874d1db-f339-49f9-8225-ca61c05f1d64", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["f988f9fb-463d-4aaa-b83d-54a3b114e570"], "manufacturer_name": ["McLane Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (57243-200-69)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "57243-200-69", "marketing_start_date": "20180416"}], "brand_name": "Loratadine", "product_id": "57243-200_9874d1db-f339-49f9-8225-ca61c05f1d64", "dosage_form": "TABLET", "product_ndc": "57243-200", "generic_name": "Loratadine", "labeler_name": "McLane Company, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA208314", "marketing_category": "ANDA", "marketing_start_date": "20180416", "listing_expiration_date": "20261231"}