claritin-d 24 hour

Generic: loratadine and pseudoephedrine sulfate

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

Drug Facts

Product Profile

Brand Name claritin-d 24 hour
Generic Name loratadine and pseudoephedrine sulfate
Labeler bayer healthcare llc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

loratadine 10 mg/1, pseudoephedrine sulfate 240 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 11523-4332
Product ID 11523-4332_45370575-1a5d-c6f1-e063-6394a90a24c4
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020470
Listing Expiration 2026-12-31
Marketing Start 2009-12-01

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115234332
Hyphenated Format 11523-4332

Supplemental Identifiers

RxCUI
1117562 1242391
UPC
0041100810861
UNII
7AJO3BO7QN Y9DL7QPE6B

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-d 24 hour (source: ndc)
Generic Name loratadine and pseudoephedrine sulfate (source: ndc)
Application Number NDA020470 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 240 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (11523-4332-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (11523-4332-3) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

11523-4332-1 1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 11523-4332-2 1 BLISTER PACK in 1 CARTON (11523-4332-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 11523-4332-3 3 BLISTER PACK in 1 CARTON (11523-4332-3) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

loratadine (10 mg/1) pseudoephedrine sulfate (240 mg/1)

Linked Drug Pages (1)

Claritin-D 24 Hour ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45370575-1a5d-c6f1-e063-6394a90a24c4", "openfda": {"upc": ["0041100810861"], "unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562", "1242391"], "spl_set_id": ["f046a807-ab8c-0620-e053-2a95a90a9d3c"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11523-4332-1)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-4332-1", "marketing_start_date": "20091201"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11523-4332-2)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-4332-2", "marketing_start_date": "20091201"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (11523-4332-3)  / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-4332-3", "marketing_start_date": "20091201"}], "brand_name": "Claritin-D 24 Hour", "product_id": "11523-4332_45370575-1a5d-c6f1-e063-6394a90a24c4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "11523-4332", "generic_name": "Loratadine and pseudoephedrine sulfate", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Claritin-D", "brand_name_suffix": "24 Hour", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "240 mg/1"}], "application_number": "NDA020470", "marketing_category": "NDA", "marketing_start_date": "20091201", "listing_expiration_date": "20261231"}