levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: chain drug marketing association inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler chain drug marketing association inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Chain Drug Marketing Association INC

Identifiers & Regulatory

Product NDC 63868-473
Product ID 63868-473_62bd5a02-2f4d-697f-856c-7516352417c1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2026-12-31
Marketing Start 2020-06-24

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 63868473
Hyphenated Format 63868-473

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 (63868-473-35) / 35 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (1)

63868-473-35 1 BOTTLE in 1 CARTON (63868-473-35) / 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": "62bd5a02-2f4d-697f-856c-7516352417c1", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["61fb8bef-d868-adee-3237-d3268d603ba6"], "manufacturer_name": ["Chain Drug Marketing Association INC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63868-473-35)  / 35 TABLET, COATED in 1 BOTTLE", "package_ndc": "63868-473-35", "marketing_start_date": "20200624"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "63868-473_62bd5a02-2f4d-697f-856c-7516352417c1", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63868-473", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Chain Drug Marketing Association INC", "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": "20200624", "listing_expiration_date": "20261231"}