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 5 mg/1

Manufacturer
Premier Value

Identifiers & Regulatory

Product NDC 68016-053
Product ID 68016-053_2a409885-2a3e-34d8-e063-6394a90aa4d9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210088
Listing Expiration 2026-12-31
Marketing Start 2018-04-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016053
Hyphenated Format 68016-053

Supplemental Identifiers

RxCUI
665078
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 ANDA210088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68016-053-10) / 10 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (68016-053-30) / 30 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

68016-053-10 1 BLISTER PACK in 1 CARTON (68016-053-10) / 10 TABLET in 1 BLISTER PACK 68016-053-30 1 BLISTER PACK in 1 CARTON (68016-053-30) / 30 TABLET in 1 BLISTER PACK

Ingredients (1)

loratadine (5 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": "2a409885-2a3e-34d8-e063-6394a90aa4d9", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["665078"], "spl_set_id": ["dc22862e-fe91-4900-8c2b-1ca45aeedbf0"], "manufacturer_name": ["Premier Value"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68016-053-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "68016-053-10", "marketing_start_date": "20180401"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68016-053-30)  / 30 TABLET in 1 BLISTER PACK", "package_ndc": "68016-053-30", "marketing_start_date": "20180401"}], "brand_name": "Loratadine", "product_id": "68016-053_2a409885-2a3e-34d8-e063-6394a90aa4d9", "dosage_form": "TABLET", "product_ndc": "68016-053", "generic_name": "Loratadine", "labeler_name": "Premier Value", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA210088", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20261231"}