levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: cvs pharmacy
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler cvs pharmacy
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
CVS PHARMACY

Identifiers & Regulatory

Product NDC 69842-761
Product ID 69842-761_7839b2b5-3bfc-0bdc-9a7d-28cfd9ae6fd8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2027-12-31
Marketing Start 2018-04-15

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 69842761
Hyphenated Format 69842-761

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
  • 2 BLISTER PACK in 1 CARTON (69842-761-10) / 5 TABLET, COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (69842-761-35) / 35 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69842-761-55) / 55 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69842-761-80) / 80 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (4)

69842-761-10 2 BLISTER PACK in 1 CARTON (69842-761-10) / 5 TABLET, COATED in 1 BLISTER PACK 69842-761-35 1 BOTTLE in 1 CARTON (69842-761-35) / 35 TABLET, COATED in 1 BOTTLE 69842-761-55 1 BOTTLE in 1 CARTON (69842-761-55) / 55 TABLET, COATED in 1 BOTTLE 69842-761-80 1 BOTTLE in 1 CARTON (69842-761-80) / 80 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": "7839b2b5-3bfc-0bdc-9a7d-28cfd9ae6fd8", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["c8681ca3-27b4-6738-af72-599ff05f2ec8"], "manufacturer_name": ["CVS PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69842-761-10)  / 5 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "69842-761-10", "marketing_start_date": "20181231"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69842-761-35)  / 35 TABLET, COATED in 1 BOTTLE", "package_ndc": "69842-761-35", "marketing_start_date": "20180415"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69842-761-55)  / 55 TABLET, COATED in 1 BOTTLE", "package_ndc": "69842-761-55", "marketing_start_date": "20221130"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69842-761-80)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "69842-761-80", "marketing_start_date": "20180415"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "69842-761_7839b2b5-3bfc-0bdc-9a7d-28cfd9ae6fd8", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69842-761", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "CVS PHARMACY", "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": "20180415", "listing_expiration_date": "20271231"}