claritin

Generic: loratadine

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name claritin
Generic Name loratadine
Labeler bayer healthcare llc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 11523-0800
Product ID 11523-0800_4526e2eb-ee8d-3ac4-e063-6394a90a133f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075209
Listing Expiration 2026-12-31
Marketing Start 2020-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115230800
Hyphenated Format 11523-0800

Supplemental Identifiers

RxCUI
206805 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 claritin (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA075209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (11523-0800-1) / 5 TABLET in 1 BLISTER PACK
  • 100 TABLET in 1 BOTTLE (11523-0800-2)
source: ndc

Packages (2)

11523-0800-1 1 BLISTER PACK in 1 CARTON (11523-0800-1) / 5 TABLET in 1 BLISTER PACK 11523-0800-2 100 TABLET in 1 BOTTLE (11523-0800-2)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Claritin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4526e2eb-ee8d-3ac4-e063-6394a90a133f", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["206805", "311372"], "spl_set_id": ["dc65f7ec-bb83-7b29-e053-2995a90a99de"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11523-0800-1)  / 5 TABLET in 1 BLISTER PACK", "package_ndc": "11523-0800-1", "marketing_start_date": "20220316"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (11523-0800-2)", "package_ndc": "11523-0800-2", "marketing_start_date": "20220316"}], "brand_name": "Claritin", "product_id": "11523-0800_4526e2eb-ee8d-3ac4-e063-6394a90a133f", "dosage_form": "TABLET", "product_ndc": "11523-0800", "generic_name": "loratadine", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Claritin", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA075209", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}