levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levocetirizine dihydrochloride
Generic Name levocetirizine dihydrochloride
Labeler preferred pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7699
Product ID 68788-7699_b28d2f77-41ff-461f-bba3-9278feab322a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202046
Listing Expiration 2026-12-31
Marketing Start 2020-04-01

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 687887699
Hyphenated Format 68788-7699

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 ANDA202046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-7699-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-7699-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-7699-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-7699-9)
source: ndc

Packages (4)

68788-7699-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-7699-1) 68788-7699-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7699-3) 68788-7699-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-7699-6) 68788-7699-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-7699-9)

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": "b28d2f77-41ff-461f-bba3-9278feab322a", "openfda": {"unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["30bf11cc-cf60-441f-9eea-6dfbe740923e"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-7699-1)", "package_ndc": "68788-7699-1", "marketing_start_date": "20200401"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-7699-3)", "package_ndc": "68788-7699-3", "marketing_start_date": "20200402"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7699-6)", "package_ndc": "68788-7699-6", "marketing_start_date": "20200401"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-7699-9)", "package_ndc": "68788-7699-9", "marketing_start_date": "20200401"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "68788-7699_b28d2f77-41ff-461f-bba3-9278feab322a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-7699", "generic_name": "levocetirizine Dihydrochloride", "labeler_name": "Preferred Pharmaceuticals, Inc.", "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": "20200401", "listing_expiration_date": "20261231"}