levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

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

Drug Facts

Product Profile

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

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7701
Product ID 0093-7701_27746553-05ff-43dd-a541-26bb9a6e9a4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090199
Listing Expiration 2026-12-31
Marketing Start 2011-09-06

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 00937701
Hyphenated Format 0093-7701

Supplemental Identifiers

RxCUI
855172
UPC
0300937701989
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 ANDA090199 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98)
source: ndc

Packages (1)

0093-7701-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98)

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": "27746553-05ff-43dd-a541-26bb9a6e9a4c", "openfda": {"upc": ["0300937701989"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["4f43d057-cba8-4366-86ba-4be361e4c71f"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98)", "package_ndc": "0093-7701-98", "marketing_start_date": "20110906"}], "brand_name": "Levocetirizine Dihydrochloride", "product_id": "0093-7701_27746553-05ff-43dd-a541-26bb9a6e9a4c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0093-7701", "generic_name": "Levocetirizine Dihydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levocetirizine Dihydrochloride", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090199", "marketing_category": "ANDA", "marketing_start_date": "20110906", "listing_expiration_date": "20261231"}