levocetirizine dihydrochloride

Generic: levocetirizine dihydrochloride

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

Drug Facts

Product Profile

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

levocetirizine dihydrochloride 5 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-346
Product ID 68462-346_3dc84568-462c-4fca-b235-3a84f8a4bd7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090385
Listing Expiration 2027-12-31
Marketing Start 2011-02-25

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 68462346
Hyphenated Format 68462-346

Supplemental Identifiers

RxCUI
855172
UPC
0368462346907
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 ANDA090385 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (68462-346-90)
source: ndc

Packages (1)

68462-346-90 90 TABLET in 1 BOTTLE (68462-346-90)

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": "3dc84568-462c-4fca-b235-3a84f8a4bd7e", "openfda": {"upc": ["0368462346907"], "unii": ["SOD6A38AGA"], "rxcui": ["855172"], "spl_set_id": ["60ae7e0e-281c-40a3-a0d3-259b843ddaaa"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68462-346-90)", "package_ndc": "68462-346-90", "marketing_start_date": "20110225"}], "brand_name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "product_id": "68462-346_3dc84568-462c-4fca-b235-3a84f8a4bd7e", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68462-346", "generic_name": "levocetirizine dihydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOCETIRIZINE DIHYDROCHLORIDE", "active_ingredients": [{"name": "LEVOCETIRIZINE DIHYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090385", "marketing_category": "ANDA", "marketing_start_date": "20110225", "listing_expiration_date": "20271231"}