levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0789
Product ID 71335-0789_4677b1a2-8516-44c2-9d61-0f033b40617c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091264
Listing Expiration 2026-12-31
Marketing Start 2012-06-29

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 713350789
Hyphenated Format 71335-0789

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 ANDA091264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71335-0789-1)
  • 90 TABLET in 1 BOTTLE (71335-0789-2)
  • 28 TABLET in 1 BOTTLE (71335-0789-3)
  • 60 TABLET in 1 BOTTLE (71335-0789-4)
source: ndc

Packages (4)

71335-0789-1 30 TABLET in 1 BOTTLE (71335-0789-1) 71335-0789-2 90 TABLET in 1 BOTTLE (71335-0789-2) 71335-0789-3 28 TABLET in 1 BOTTLE (71335-0789-3) 71335-0789-4 60 TABLET in 1 BOTTLE (71335-0789-4)

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": "4677b1a2-8516-44c2-9d61-0f033b40617c", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["b7bbffcb-5f56-4735-998a-eadd07dfa2cb"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-0789-1)", "package_ndc": "71335-0789-1", "marketing_start_date": "20190111"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-0789-2)", "package_ndc": "71335-0789-2", "marketing_start_date": "20180517"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71335-0789-3)", "package_ndc": "71335-0789-3", "marketing_start_date": "20211227"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-0789-4)", "package_ndc": "71335-0789-4", "marketing_start_date": "20211227"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "71335-0789_4677b1a2-8516-44c2-9d61-0f033b40617c", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71335-0789", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA091264", "marketing_category": "ANDA", "marketing_start_date": "20120629", "listing_expiration_date": "20261231"}