levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler micro labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-122
Product ID 42571-122_3b48813c-9d13-7de6-e063-6294a90ac278
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202046
Listing Expiration 2026-12-31
Marketing Start 2013-09-30

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 42571122
Hyphenated Format 42571-122

Supplemental Identifiers

RxCUI
855172
UPC
0342571122904
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 levocetirizine dihydrochloride (source: ndc)
Generic Name levocetirizine dihydrochloride (source: ndc)
Application Number ANDA202046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (42571-122-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42571-122-30)
  • 10 BLISTER PACK in 1 CARTON (42571-122-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-122-11)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42571-122-90)
source: ndc

Packages (4)

42571-122-05 500 TABLET, FILM COATED in 1 BOTTLE (42571-122-05) 42571-122-30 30 TABLET, FILM COATED in 1 BOTTLE (42571-122-30) 42571-122-32 10 BLISTER PACK in 1 CARTON (42571-122-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-122-11) 42571-122-90 90 TABLET, FILM COATED in 1 BOTTLE (42571-122-90)

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": "3b48813c-9d13-7de6-e063-6294a90ac278", "openfda": {"upc": ["0342571122904"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["717eb542-3a05-485e-be76-3930efb40d33"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42571-122-05)", "package_ndc": "42571-122-05", "marketing_start_date": "20130930"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42571-122-30)", "package_ndc": "42571-122-30", "marketing_start_date": "20130930"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (42571-122-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-122-11)", "package_ndc": "42571-122-32", "marketing_start_date": "20130930"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42571-122-90)", "package_ndc": "42571-122-90", "marketing_start_date": "20130930"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "42571-122_3b48813c-9d13-7de6-e063-6294a90ac278", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "42571-122", "generic_name": "levocetirizine Dihydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA202046", "marketing_category": "ANDA", "marketing_start_date": "20130930", "listing_expiration_date": "20261231"}