loratadine

Generic: loratadine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-423
Product ID 71610-423_c1e2a0e1-48b7-4481-8ed8-3197bf7d05a2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076301
Listing Expiration 2026-12-31
Marketing Start 2018-12-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610423
Hyphenated Format 71610-423

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 (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA076301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-423-60)
source: ndc

Packages (1)

71610-423-60 90 TABLET in 1 BOTTLE (71610-423-60)

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": "c1e2a0e1-48b7-4481-8ed8-3197bf7d05a2", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["8ffe2faf-3253-4121-a069-6f46e319c6f0"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-423-60)", "package_ndc": "71610-423-60", "marketing_start_date": "20200501"}], "brand_name": "Loratadine", "product_id": "71610-423_c1e2a0e1-48b7-4481-8ed8-3197bf7d05a2", "dosage_form": "TABLET", "product_ndc": "71610-423", "generic_name": "Loratadine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076301", "marketing_category": "ANDA", "marketing_start_date": "20181206", "listing_expiration_date": "20261231"}