levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: united natural foods, inc. dba unfi
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler united natural foods, inc. dba unfi
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
United Natural Foods, Inc. dba UNFI

Identifiers & Regulatory

Product NDC 41163-938
Product ID 41163-938_a9a6a71e-7f90-7204-983a-10736fd7814e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2026-12-31
Marketing Start 2018-12-31

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 41163938
Hyphenated Format 41163-938

Supplemental Identifiers

RxCUI
855172
UNII
SOD6A38AGA

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 levocetirizine dihydrochloride (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number ANDA210375 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (41163-938-35) / 35 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (1)

41163-938-35 1 BOTTLE in 1 CARTON (41163-938-35) / 35 TABLET, COATED in 1 BOTTLE

Ingredients (1)

levocetirizine dihydrochloride (5 mg/1)

Linked Drug Pages (1)

levocetirizine dihydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a9a6a71e-7f90-7204-983a-10736fd7814e", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["5036170d-7eeb-65a8-8473-7d98aeb51ee4"], "manufacturer_name": ["United Natural Foods, Inc. dba UNFI"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (41163-938-35)  / 35 TABLET, COATED in 1 BOTTLE", "package_ndc": "41163-938-35", "marketing_start_date": "20181231"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "41163-938_a9a6a71e-7f90-7204-983a-10736fd7814e", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "41163-938", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "United Natural Foods, Inc. dba UNFI", "product_type": "HUMAN OTC DRUG", "brand_name_base": "levocetirizine dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA210375", "marketing_category": "ANDA", "marketing_start_date": "20181231", "listing_expiration_date": "20261231"}