claritin-d 12 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 12 hour
Generic Name loratadine and pseudoephedrine sulfate
Labeler bayer healthcare llc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

loratadine 5 mg/1, pseudoephedrine sulfate 120 mg/1

Manufacturer
Bayer HealthCare LLC.

Identifiers & Regulatory

Product NDC 11523-7162
Product ID 11523-7162_45371982-daab-f344-e063-6394a90a2f41
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019670
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 115237162
Hyphenated Format 11523-7162

Supplemental Identifiers

RxCUI
1242399 1242406
UPC
0041100802088
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 12 hour (source: ndc)
Generic Name loratadine and pseudoephedrine sulfate (source: ndc)
Application Number NDA019670 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 120 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (11523-7162-3) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

11523-7162-1 1 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 11523-7162-2 2 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 11523-7162-3 3 BLISTER PACK in 1 CARTON (11523-7162-3) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

loratadine (5 mg/1) pseudoephedrine sulfate (120 mg/1)

Linked Drug Pages (1)

Claritin-D 12 Hour ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45371982-daab-f344-e063-6394a90a2f41", "openfda": {"upc": ["0041100802088"], "unii": ["7AJO3BO7QN", "Y9DL7QPE6B"], "rxcui": ["1242399", "1242406"], "spl_set_id": ["a7125705-01ff-4418-8c53-9209c2bbb484"], "manufacturer_name": ["Bayer HealthCare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (11523-7162-1)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-7162-1", "marketing_start_date": "20091201"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (11523-7162-2)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-7162-2", "marketing_start_date": "20091201"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (11523-7162-3)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "11523-7162-3", "marketing_start_date": "20091201"}], "brand_name": "Claritin-D 12 Hour", "product_id": "11523-7162_45371982-daab-f344-e063-6394a90a2f41", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "11523-7162", "generic_name": "Loratadine and pseudoephedrine sulfate", "labeler_name": "Bayer HealthCare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Claritin-D", "brand_name_suffix": "12 Hour", "active_ingredients": [{"name": "LORATADINE", "strength": "5 mg/1"}, {"name": "PSEUDOEPHEDRINE SULFATE", "strength": "120 mg/1"}], "application_number": "NDA019670", "marketing_category": "NDA", "marketing_start_date": "20091201", "listing_expiration_date": "20261231"}