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, CHEWABLE
Routes
ORAL
Active Ingredients

loratadine 5 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 11523-0104
Product ID 11523-0104_4526d753-7999-0ec3-e063-6294a90a270f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210033
Listing Expiration 2026-12-31
Marketing Start 2023-02-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115230104
Hyphenated Format 11523-0104

Supplemental Identifiers

RxCUI
665078 668469
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 ANDA210033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (11523-0104-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (11523-0104-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (11523-0104-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (11523-0104-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (11523-0104-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 8 BLISTER PACK in 1 CARTON (11523-0104-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (6)

11523-0104-1 1 BLISTER PACK in 1 CARTON (11523-0104-1) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 11523-0104-2 2 BLISTER PACK in 1 CARTON (11523-0104-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 11523-0104-3 3 BLISTER PACK in 1 CARTON (11523-0104-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 11523-0104-4 4 BLISTER PACK in 1 CARTON (11523-0104-4) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 11523-0104-5 6 BLISTER PACK in 1 CARTON (11523-0104-5) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 11523-0104-6 8 BLISTER PACK in 1 CARTON (11523-0104-6) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

loratadine (5 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": "4526d753-7999-0ec3-e063-6294a90a270f", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["665078", "668469"], "spl_set_id": ["f3b9c643-a605-7702-e053-2995a90a6130"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11523-0104-1)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11523-0104-1", "marketing_start_date": "20230208"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (11523-0104-2)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11523-0104-2", "marketing_start_date": "20230208"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (11523-0104-3)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11523-0104-3", "marketing_start_date": "20230208"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (11523-0104-4)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11523-0104-4", "marketing_start_date": "20230208"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (11523-0104-5)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11523-0104-5", "marketing_start_date": "20230208"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (11523-0104-6)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "11523-0104-6", "marketing_start_date": "20230205"}], "brand_name": "Claritin", "product_id": "11523-0104_4526d753-7999-0ec3-e063-6294a90a270f", "dosage_form": "TABLET, CHEWABLE", "product_ndc": "11523-0104", "generic_name": "Loratadine", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Claritin", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}], "application_number": "ANDA210033", "marketing_category": "ANDA", "marketing_start_date": "20230205", "listing_expiration_date": "20261231"}