levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

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

Drug Facts

Product Profile

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

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-312
Product ID 42571-312_2e504864-a08d-48e1-e063-6394a90a92ed
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211551
Listing Expiration 2026-12-31
Marketing Start 2019-02-01

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 42571312
Hyphenated Format 42571-312

Supplemental Identifiers

RxCUI
855172
UPC
0342571312909
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 ANDA211551 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (42571-312-11) / 10 TABLET in 1 BLISTER PACK (42571-312-32)
  • 1 BOTTLE in 1 CARTON (42571-312-18) / 10 TABLET in 1 BOTTLE
  • 2500 TABLET in 1 POUCH (42571-312-53)
  • 1 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (4)

42571-312-11 100 BLISTER PACK in 1 CARTON (42571-312-11) / 10 TABLET in 1 BLISTER PACK (42571-312-32) 42571-312-18 1 BOTTLE in 1 CARTON (42571-312-18) / 10 TABLET in 1 BOTTLE 42571-312-53 2500 TABLET in 1 POUCH (42571-312-53) 42571-312-90 1 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET 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": "2e504864-a08d-48e1-e063-6394a90a92ed", "openfda": {"upc": ["0342571312909"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["78ff8e86-ee5b-4626-aa81-49e974febf1d"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (42571-312-11)  / 10 TABLET in 1 BLISTER PACK (42571-312-32)", "package_ndc": "42571-312-11", "marketing_start_date": "20190201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (42571-312-18)  / 10 TABLET in 1 BOTTLE", "package_ndc": "42571-312-18", "marketing_start_date": "20190201"}, {"sample": false, "description": "2500 TABLET in 1 POUCH (42571-312-53)", "package_ndc": "42571-312-53", "marketing_start_date": "20190201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (42571-312-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "42571-312-90", "marketing_start_date": "20190201"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "42571-312_2e504864-a08d-48e1-e063-6394a90a92ed", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "42571-312", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA211551", "marketing_category": "ANDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}