xyzal allergy 24hr

Generic: levocetirizine dihydrochloride

Labeler: chattem, inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xyzal allergy 24hr
Generic Name levocetirizine dihydrochloride
Labeler chattem, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Chattem, Inc.

Identifiers & Regulatory

Product NDC 41167-3511
Product ID 41167-3511_f43bc46c-c507-4ccf-9b93-17eaeebf4ed5
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA209089
Listing Expiration 2027-12-31
Marketing Start 2023-09-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 411673511
Hyphenated Format 41167-3511

Supplemental Identifiers

RxCUI
855172 855174
UNII
SOD6A38AGA

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 xyzal allergy 24hr (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number NDA209089 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (41167-3511-2) / 20 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (41167-3511-8) / 40 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (41167-3511-9) / 60 TABLET in 1 BLISTER PACK
source: ndc

Packages (3)

41167-3511-2 1 BLISTER PACK in 1 CARTON (41167-3511-2) / 20 TABLET in 1 BLISTER PACK 41167-3511-8 1 BLISTER PACK in 1 CARTON (41167-3511-8) / 40 TABLET in 1 BLISTER PACK 41167-3511-9 1 BLISTER PACK in 1 CARTON (41167-3511-9) / 60 TABLET in 1 BLISTER PACK

Ingredients (1)

levocetirizine dihydrochloride (5 mg/1)

Linked Drug Pages (1)

Xyzal Allergy 24HR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f43bc46c-c507-4ccf-9b93-17eaeebf4ed5", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172", "855174"], "spl_set_id": ["8be45c2a-1eca-4a00-81b9-f7babdbdcd41"], "manufacturer_name": ["Chattem, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (41167-3511-2)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "41167-3511-2", "marketing_start_date": "20230901"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (41167-3511-8)  / 40 TABLET in 1 BLISTER PACK", "package_ndc": "41167-3511-8", "marketing_start_date": "20260101"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (41167-3511-9)  / 60 TABLET in 1 BLISTER PACK", "package_ndc": "41167-3511-9", "marketing_start_date": "20260101"}], "brand_name": "Xyzal Allergy 24HR", "product_id": "41167-3511_f43bc46c-c507-4ccf-9b93-17eaeebf4ed5", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "41167-3511", "generic_name": "Levocetirizine dihydrochloride", "labeler_name": "Chattem, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Xyzal Allergy 24HR", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "NDA209089", "marketing_category": "NDA", "marketing_start_date": "20230901", "listing_expiration_date": "20271231"}