claritin-d 24 hour

Generic: loratadine pseudoephedrine sulfate

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

Drug Facts

Product Profile

Brand Name claritin-d 24 hour
Generic Name loratadine 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 11523-0102
Product ID 11523-0102_4526d9ef-02fb-338e-e063-6394a90af108
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075706
Listing Expiration 2026-12-31
Marketing Start 2022-12-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115230102
Hyphenated Format 11523-0102

Supplemental Identifiers

RxCUI
1117562 1242391
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 pseudoephedrine sulfate (source: ndc)
Application Number ANDA075706 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 240 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (11523-0102-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (11523-0102-2) / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

11523-0102-1 1 BLISTER PACK in 1 CARTON (11523-0102-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 11523-0102-2 1 BLISTER PACK in 1 CARTON (11523-0102-2) / 15 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": "4526d9ef-02fb-338e-e063-6394a90af108", "openfda": {"unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1117562", "1242391"], "spl_set_id": ["3ea6a90b-8cb1-46b0-9ff7-be7090245e53"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11523-0102-1)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-0102-1", "marketing_start_date": "20221212"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11523-0102-2)  / 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-0102-2", "marketing_start_date": "20221212"}], "brand_name": "Claritin-D 24 Hour", "product_id": "11523-0102_4526d9ef-02fb-338e-e063-6394a90af108", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "11523-0102", "generic_name": "Loratadine 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": "ANDA075706", "marketing_category": "ANDA", "marketing_start_date": "20221212", "listing_expiration_date": "20261231"}