levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: walgreens company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler walgreens company
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Walgreens Company

Identifiers & Regulatory

Product NDC 0363-5529
Product ID 0363-5529_7d5d0782-387a-6951-f77d-da28a0065fef
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210375
Listing Expiration 2027-12-31
Marketing Start 2018-03-26

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 03635529
Hyphenated Format 0363-5529

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 (0363-5529-10) / 5 TABLET, COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (0363-5529-12) / 120 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0363-5529-35) / 35 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0363-5529-55) / 55 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0363-5529-80) / 80 TABLET, COATED in 1 BOTTLE
source: ndc

Packages (5)

0363-5529-10 2 BLISTER PACK in 1 CARTON (0363-5529-10) / 5 TABLET, COATED in 1 BLISTER PACK 0363-5529-12 1 BOTTLE in 1 CARTON (0363-5529-12) / 120 TABLET, COATED in 1 BOTTLE 0363-5529-35 1 BOTTLE in 1 CARTON (0363-5529-35) / 35 TABLET, COATED in 1 BOTTLE 0363-5529-55 1 BOTTLE in 1 CARTON (0363-5529-55) / 55 TABLET, COATED in 1 BOTTLE 0363-5529-80 1 BOTTLE in 1 CARTON (0363-5529-80) / 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": "7d5d0782-387a-6951-f77d-da28a0065fef", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["766b8836-74b8-8af7-b900-b813b4fc175b"], "manufacturer_name": ["Walgreens Company"]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0363-5529-10)  / 5 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0363-5529-10", "marketing_start_date": "20180417"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-5529-12)  / 120 TABLET, COATED in 1 BOTTLE", "package_ndc": "0363-5529-12", "marketing_start_date": "20210115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-5529-35)  / 35 TABLET, COATED in 1 BOTTLE", "package_ndc": "0363-5529-35", "marketing_start_date": "20180326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-5529-55)  / 55 TABLET, COATED in 1 BOTTLE", "package_ndc": "0363-5529-55", "marketing_start_date": "20180326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-5529-80)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "0363-5529-80", "marketing_start_date": "20180326"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "0363-5529_7d5d0782-387a-6951-f77d-da28a0065fef", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0363-5529", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Walgreens Company", "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": "20180326", "listing_expiration_date": "20271231"}