levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: dr.reddy's laboratories ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler dr.reddy's laboratories ltd.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Dr.Reddy's laboratories Ltd.

Identifiers & Regulatory

Product NDC 55111-282
Product ID 55111-282_acb3404e-c2a4-f21f-5f5b-f0ceab355395
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090392
Listing Expiration 2026-12-31
Marketing Start 2011-02-24

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 55111282
Hyphenated Format 55111-282

Supplemental Identifiers

RxCUI
855172
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 ANDA090392 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (55111-282-01)
  • 500 TABLET, COATED in 1 BOTTLE (55111-282-05)
  • 180 TABLET, COATED in 1 BOTTLE (55111-282-18)
  • 30 TABLET, COATED in 1 BOTTLE (55111-282-30)
  • 60 TABLET, COATED in 1 BOTTLE (55111-282-60)
  • 10 BLISTER PACK in 1 CARTON (55111-282-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79)
  • 90 TABLET, COATED in 1 BOTTLE (55111-282-90)
source: ndc

Packages (7)

55111-282-01 100 TABLET, COATED in 1 BOTTLE (55111-282-01) 55111-282-05 500 TABLET, COATED in 1 BOTTLE (55111-282-05) 55111-282-18 180 TABLET, COATED in 1 BOTTLE (55111-282-18) 55111-282-30 30 TABLET, COATED in 1 BOTTLE (55111-282-30) 55111-282-60 60 TABLET, COATED in 1 BOTTLE (55111-282-60) 55111-282-78 10 BLISTER PACK in 1 CARTON (55111-282-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79) 55111-282-90 90 TABLET, COATED in 1 BOTTLE (55111-282-90)

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": "acb3404e-c2a4-f21f-5f5b-f0ceab355395", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["c40c1bb4-25ce-90cb-b8dd-6a4c54cddd4a"], "manufacturer_name": ["Dr.Reddy's laboratories Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (55111-282-01)", "package_ndc": "55111-282-01", "marketing_start_date": "20110224"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (55111-282-05)", "package_ndc": "55111-282-05", "marketing_start_date": "20110224"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE (55111-282-18)", "package_ndc": "55111-282-18", "marketing_start_date": "20110224"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (55111-282-30)", "package_ndc": "55111-282-30", "marketing_start_date": "20110224"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (55111-282-60)", "package_ndc": "55111-282-60", "marketing_start_date": "20110224"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-282-78)  / 10 TABLET, COATED in 1 BLISTER PACK (55111-282-79)", "package_ndc": "55111-282-78", "marketing_start_date": "20110224"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (55111-282-90)", "package_ndc": "55111-282-90", "marketing_start_date": "20110224"}], "brand_name": "levocetirizine dihydrochloride", "product_id": "55111-282_acb3404e-c2a4-f21f-5f5b-f0ceab355395", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55111-282", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Dr.Reddy's laboratories Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levocetirizine dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090392", "marketing_category": "ANDA", "marketing_start_date": "20110224", "listing_expiration_date": "20261231"}