loratadine

Generic: loratadine

Labeler: cardinal health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler cardinal health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Cardinal Health

Identifiers & Regulatory

Product NDC 70000-0583
Product ID 70000-0583_57c1fc35-94df-4613-bfec-97f1dd995df0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208314
Listing Expiration 2026-12-31
Marketing Start 2021-08-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000583
Hyphenated Format 70000-0583

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
  • 2 BLISTER PACK in 1 CARTON (70000-0583-1) / 10 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (70000-0583-2) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (2)

70000-0583-1 2 BLISTER PACK in 1 CARTON (70000-0583-1) / 10 TABLET in 1 BLISTER PACK 70000-0583-2 1 BOTTLE in 1 CARTON (70000-0583-2) / 30 TABLET in 1 BOTTLE

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": "57c1fc35-94df-4613-bfec-97f1dd995df0", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["c96dd1c9-85a0-0792-e053-2a95a90a2264"], "manufacturer_name": ["Cardinal Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (70000-0583-1)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70000-0583-1", "marketing_start_date": "20210830"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0583-2)  / 30 TABLET in 1 BOTTLE", "package_ndc": "70000-0583-2", "marketing_start_date": "20240614"}], "brand_name": "Loratadine", "product_id": "70000-0583_57c1fc35-94df-4613-bfec-97f1dd995df0", "dosage_form": "TABLET", "product_ndc": "70000-0583", "generic_name": "Loratadine", "labeler_name": "Cardinal Health", "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": "20210830", "listing_expiration_date": "20261231"}