loratadine

Generic: loratadine

Labeler: premier value
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler premier value
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Premier Value

Identifiers & Regulatory

Product NDC 68016-526
Product ID 68016-526_78c14cff-325e-4106-a9a4-cb5281ceec58
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076134
Listing Expiration 2026-12-31
Marketing Start 2003-08-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016526
Hyphenated Format 68016-526

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 ANDA076134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (68016-526-31)
  • 60 TABLET in 1 BOTTLE (68016-526-60)
  • 10 TABLET in 1 BLISTER PACK (68016-526-69)
  • 90 TABLET in 1 BOTTLE (68016-526-90)
source: ndc

Packages (4)

68016-526-31 30 TABLET in 1 BLISTER PACK (68016-526-31) 68016-526-60 60 TABLET in 1 BOTTLE (68016-526-60) 68016-526-69 10 TABLET in 1 BLISTER PACK (68016-526-69) 68016-526-90 90 TABLET in 1 BOTTLE (68016-526-90)

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": "78c14cff-325e-4106-a9a4-cb5281ceec58", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["778a6979-ea47-4381-8c40-84b3c2325a7e"], "manufacturer_name": ["Premier Value"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (68016-526-31)", "package_ndc": "68016-526-31", "marketing_start_date": "20030819"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68016-526-60)", "package_ndc": "68016-526-60", "marketing_start_date": "20030819"}, {"sample": false, "description": "10 TABLET in 1 BLISTER PACK (68016-526-69)", "package_ndc": "68016-526-69", "marketing_start_date": "20030819"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68016-526-90)", "package_ndc": "68016-526-90", "marketing_start_date": "20030819"}], "brand_name": "Loratadine", "product_id": "68016-526_78c14cff-325e-4106-a9a4-cb5281ceec58", "dosage_form": "TABLET", "product_ndc": "68016-526", "generic_name": "Loratadine", "labeler_name": "Premier Value", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA076134", "marketing_category": "ANDA", "marketing_start_date": "20030819", "listing_expiration_date": "20261231"}